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Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01457339
Recruitment Status : Completed
First Posted : October 21, 2011
Results First Posted : January 21, 2013
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Schizophrenia
Interventions Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Placebo
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)
Hide Arm/Group Description Placebo Capsule(s) for oral use taken once daily for 30 days Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
Period Title: Period 1 (50 mg)
Started 7 24
Completed 7 24
Not Completed 0 0
Period Title: Period 2 (70 mg)
Started 7 24
Completed 7 24
Not Completed 0 0
Period Title: Period 3 (100 mg)
Started 7 24
Completed 7 23
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Period 4 (150 mg)
Started 7 23
Completed 7 23
Not Completed 0 0
Period Title: Period 5 (200 mg)
Started 7 23
Completed 7 22
Not Completed 0 1
Reason Not Completed
Met stopping criteria for PANSS score             0             1
Period Title: Period 6 (250 mg)
Started 7 22
Completed 6 21
Not Completed 1 1
Reason Not Completed
Family Emergency             1             0
Personal appointment             0             1
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(All Doses) Total
Hide Arm/Group Description Placebo Capsule(s) for oral use taken once daily for 30 days Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). Total of all reporting groups
Overall Number of Baseline Participants 7 24 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 24 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
24
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 24 participants 31 participants
49.6  (4.93) 46.4  (7.86) 47.1  (7.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 24 participants 31 participants
Female
1
  14.3%
5
  20.8%
6
  19.4%
Male
6
  85.7%
19
  79.2%
25
  80.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 24 participants 31 participants
7 24 31
1.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.14  (9.543) 8.94  (11.510)
2.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Deviation)
Unit of Measure: mmHg
1.43  (12.593) 3.82  (9.258)
3.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: mmHg
0.43  (6.448) 4.96  (9.208)
4.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.81  (7.358) 6.43  (13.519)
5.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.38  (11.546) 5.28  (11.761)
6.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.28  (13.442) 7.36  (15.569)
7.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Deviation)
Unit of Measure: mmHg
2.86  (11.547) 5.22  (8.364)
8.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Deviation)
Unit of Measure: mmHg
2.38  (10.557) 2.14  (6.468)
9.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: mmHg
2.14  (7.796) 4.55  (7.641)
10.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: mmHg
2.67  (10.846) 2.43  (10.672)
11.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: mmHg
2.76  (14.442) 3.77  (8.041)
12.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Deviation)
Unit of Measure: mmHg
3.67  (8.618) 3.79  (10.106)
13.Primary Outcome
Title Change From Baseline in Pulse Rate at Day 5: 50 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Deviation)
Unit of Measure: beats/min
2.62  (9.534) 3.78  (11.116)
14.Primary Outcome
Title Change From Baseline in Pulse Rate at Day 5: 70 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Deviation)
Unit of Measure: beats/min
-0.95  (9.821) 5.07  (9.500)
15.Primary Outcome
Title Change From Baseline in Pulse Rate at Day 5: 100 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: beats/min
0.19  (10.306) 5.72  (12.578)
16.Primary Outcome
Title Change From Baseline in Pulse Rate at Day 5: 150 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: beats/min
-1.05  (8.125) 6.41  (13.782)
17.Primary Outcome
Title Change From Baseline in Pulse Rate at Day 5: 200 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Deviation)
Unit of Measure: beats/min
2.38  (10.058) 8.88  (12.206)
18.Primary Outcome
Title Change From Baseline in Pulse Rate at Day 5: 250 mg
Hide Description Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time Frame Baseline and day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Deviation)
Unit of Measure: beats/min
2.06  (9.760) 12.39  (12.666)
19.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
25.6  (12.9)
20.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
43.7  (27.5)
21.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
80.5  (37.2)
22.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
144.9  (43.7)
23.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
230.2  (81.1)
24.Secondary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
301.5  (105.9)
25.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng/ml
21.93  (9.96)
26.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng/ml
35.02  (21.35)
27.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: ng/ml
50.6  (18.9)
28.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: ng/ml
90.34  (30.45)
29.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: ng/ml
133.3  (63.17)
30.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Day 5 (12-hour sampling period post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
Arm/Group Title SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: ng/ml
181.53  (72.82)
31.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg
Hide Description The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
0.6  (2.22) -1.9  (1.10)
32.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg
Hide Description The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
-2.1  (1.81) -2.9  (1.50)
33.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg
Hide Description The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-3.6  (1.43) -3.9  (1.68)
34.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg
Hide Description The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-2.1  (1.40) -4.7  (1.44)
35.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg
Hide Description The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: units on a scale
-2.3  (2.01) -4.6  (1.81)
36.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg
Hide Description The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: units on a scale
-2.3  (2.03) -2.4  (2.01)
37.Secondary Outcome
Title Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg
Hide Description The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
-1.4  (1.54) -1.7  (1.09)
38.Secondary Outcome
Title Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg
Hide Description The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
-3.0  (2.85) -3.1  (1.15)
39.Secondary Outcome
Title Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg
Hide Description The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-7.0  (3.07) -2.6  (1.27)
40.Secondary Outcome
Title Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg
Hide Description The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-4.0  (3.24) -3.0  (1.17)
41.Secondary Outcome
Title Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg
Hide Description The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: units on a scale
1.3  (3.75) -2.6  (1.11)
42.Secondary Outcome
Title Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg
Hide Description The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: units on a scale
-4.2  (2.15) -3.3  (1.47)
43.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg
Hide Description CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.38) -0.3  (0.35)
44.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg
Hide Description CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.30) -0.7  (0.28)
45.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg
Hide Description CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.30) -0.9  (0.34)
46.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg
Hide Description CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-0.7  (0.47) -1.0  (0.35)
47.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg
Hide Description CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.30) -0.6  (0.28)
48.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg
Hide Description CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.40) -0.3  (0.48)
49.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg
Hide Description SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.30) 0.0  (0.18)
50.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg
Hide Description SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
-0.6  (0.43) -0.1  (0.18)
51.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg
Hide Description SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.48) 0.0  (0.21)
52.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg
Hide Description SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
-0.3  (0.29) 0.1  (0.19)
53.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg
Hide Description SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.52) 0.0  (0.20)
54.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg
Hide Description SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: units on a scale
0.2  (0.31) 0.0  (0.21)
55.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg
Hide Description BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.00) 0.0  (0.00)
56.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg
Hide Description BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.00) 0.0  (0.00)
57.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg
Hide Description BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.00) 0.0  (0.00)
58.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg
Hide Description BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.00) 0.0  (0.00)
59.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg
Hide Description BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.00) 0.2  (0.11)
60.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg
Hide Description BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: units on a scale
0.0  (0.00) 0.0  (0.05)
61.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Number of Errors
-0.9  (8.02) -8.2  (5.79)
62.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Number of Errors
8.7  (10.77) -7.3  (6.45)
63.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Number of Errors
0.9  (9.55) -15.7  (6.57)
64.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Number of Errors
21.1  (28.75) -11.3  (6.26)
65.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: Number of Errors
-10.3  (6.30) -16.5  (6.65)
66.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: Number of Errors
-5.0  (8.74) -13.2  (5.25)
67.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.0  (0.0389) -0.034  (0.0223)
68.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.017  (0.0411) -0.015  (0.0195)
69.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.014  (0.0492) -0.047  (0.0246)
70.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.037  (0.0373) -0.039  (0.0180)
71.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
-0.025  (0.0395) -0.049  (0.0178)
72.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
-0.034  (0.0581) -0.048  (0.0147)
73.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.028  (0.0304) 0.001  (0.0141)
74.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.015  (0.0273) 0.006  (0.0113)
75.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.011  (0.0348) 0.001  (0.0171)
76.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.036  (0.0419) -0.010  (0.0172)
77.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.044  (0.0397) -0.014  (0.0157)
78.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: Log10 milliseconds
0.005  (0.0531) -0.007  (0.0144)
79.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 50 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Arcsine proportion correct
0.025  (0.0234) 0.005  (0.0179)
80.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(70 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 70 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 24
Mean (Standard Error)
Unit of Measure: Arcsine proportion correct
0.015  (0.0322) 0.021  (0.0189)
81.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(100 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 100 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Arcsine proportion correct
0.012  (0.0373) 0.012  (0.0197)
82.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(150 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 150 mg dose of SPD 489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 23
Mean (Standard Error)
Unit of Measure: Arcsine proportion correct
0.026  (0.0415) 0.042  (0.0222)
83.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(200 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 200 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 7 22
Mean (Standard Error)
Unit of Measure: Arcsine proportion correct
-0.020  (0.0394) 0.046  (0.0219)
84.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg
Hide Description This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time Frame Baseline and Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(250 mg)
Hide Arm/Group Description:
Placebo Capsule(s) for oral use taken once daily for 5 days
Oral 250 mg dose of SPD489 administered once daily for 5 days.
Overall Number of Participants Analyzed 6 22
Mean (Standard Error)
Unit of Measure: Arcsine proportion correct
0.018  (0.0432) 0.022  (0.0250)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg) SPD489 (Lisdexamfetamine Dimesylate)(70 mg) SPD489 (Lisdexamfetamine Dimesylate)(100 mg) SPD489 (Lisdexamfetamine Dimesylate)(150 mg) SPD489 (Lisdexamfetamine Dimesylate)(200 mg) SPD489 (Lisdexamfetamine Dimesylate)(250 mg) SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
Hide Arm/Group Description Placebo Capsule(s) for oral use taken once daily for 30 days Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
All-Cause Mortality
Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg) SPD489 (Lisdexamfetamine Dimesylate)(70 mg) SPD489 (Lisdexamfetamine Dimesylate)(100 mg) SPD489 (Lisdexamfetamine Dimesylate)(150 mg) SPD489 (Lisdexamfetamine Dimesylate)(200 mg) SPD489 (Lisdexamfetamine Dimesylate)(250 mg) SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg) SPD489 (Lisdexamfetamine Dimesylate)(70 mg) SPD489 (Lisdexamfetamine Dimesylate)(100 mg) SPD489 (Lisdexamfetamine Dimesylate)(150 mg) SPD489 (Lisdexamfetamine Dimesylate)(200 mg) SPD489 (Lisdexamfetamine Dimesylate)(250 mg) SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/23 (0.00%)      0/23 (0.00%)      0/22 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo SPD489 (Lisdexamfetamine Dimesylate)(50 mg) SPD489 (Lisdexamfetamine Dimesylate)(70 mg) SPD489 (Lisdexamfetamine Dimesylate)(100 mg) SPD489 (Lisdexamfetamine Dimesylate)(150 mg) SPD489 (Lisdexamfetamine Dimesylate)(200 mg) SPD489 (Lisdexamfetamine Dimesylate)(250 mg) SPD489 (Lisdexamfetamine Dimesylate)(All Doses)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/7 (57.14%)      15/24 (62.50%)      7/24 (29.17%)      8/24 (33.33%)      12/23 (52.17%)      10/23 (43.48%)      12/22 (54.55%)      23/24 (95.83%)    
Cardiac disorders                 
Tachycardia  2/7 (28.57%)  2 3/24 (12.50%)  3 1/24 (4.17%)  1 1/24 (4.17%)  1 2/23 (8.70%)  2 0/23 (0.00%)  0 1/22 (4.55%)  1 6/24 (25.00%)  8
Eye disorders                 
Vision blurred  0/7 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 1/23 (4.35%)  1 1/22 (4.55%)  1 2/24 (8.33%)  2
Gastrointestinal disorders                 
Constipation  0/7 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/23 (0.00%)  0 3/23 (13.04%)  3 0/22 (0.00%)  0 5/24 (20.83%)  5
Nausea  1/7 (14.29%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 3/23 (13.04%)  3 2/23 (8.70%)  2 2/22 (9.09%)  2 4/24 (16.67%)  7
Diarrhea  0/7 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0 2/24 (8.33%)  2
Dry Mouth  0/7 (0.00%)  0 1/24 (4.17%)  1 1/24 (4.17%)  1 1/24 (4.17%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0 3/24 (12.50%)  4
Dyspepsia  0/7 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1 2/24 (8.33%)  2
Vomiting  1/7 (14.29%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1 1/24 (4.17%)  1
Infections and infestations                 
Folliculitis  0/7 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 2/22 (9.09%)  2 2/24 (8.33%)  2
Investigations                 
Blood Pressure Increased  0/7 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1 2/24 (8.33%)  2
Metabolism and nutrition disorders                 
Decreased appetite  0/7 (0.00%)  0 4/24 (16.67%)  4 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0 4/24 (16.67%)  4
Increased Appetite  1/7 (14.29%)  1 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1 2/24 (8.33%)  2
Musculoskeletal and connective tissue disorders                 
Muscle Spasms  1/7 (14.29%)  1 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0 1/24 (4.17%)  1
Musculoskeletal Pain  1/7 (14.29%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders                 
Headache  1/7 (14.29%)  1 1/24 (4.17%)  1 0/24 (0.00%)  0 1/24 (4.17%)  1 4/23 (17.39%)  5 1/23 (4.35%)  1 4/22 (18.18%)  5 4/24 (16.67%)  13
Tremor  1/7 (14.29%)  1 1/24 (4.17%)  1 1/24 (4.17%)  1 1/24 (4.17%)  1 2/23 (8.70%)  2 1/23 (4.35%)  1 1/22 (4.55%)  1 5/24 (20.83%)  7
Akathisia  0/7 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 1/23 (4.35%)  1 0/22 (0.00%)  0 2/24 (8.33%)  2
Syncope Vasovagal  1/7 (14.29%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0 0/24 (0.00%)  0
Psychiatric disorders                 
Insomnia  0/7 (0.00%)  0 3/24 (12.50%)  3 1/24 (4.17%)  1 1/24 (4.17%)  1 2/23 (8.70%)  2 0/23 (0.00%)  0 1/22 (4.55%)  1 5/24 (20.83%)  8
Anxiety  0/7 (0.00%)  0 2/24 (8.33%)  2 1/24 (4.17%)  1 0/24 (0.00%)  0 0/23 (0.00%)  0 0/23 (0.00%)  0 2/22 (9.09%)  2 4/24 (16.67%)  5
Psychotic Disorder  0/7 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/23 (4.35%)  1 1/23 (4.35%)  1 0/22 (0.00%)  0 2/24 (8.33%)  2
Reproductive system and breast disorders                 
Dysmenorrhea  0/7 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/23 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0 2/24 (8.33%)  2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: 1 866-842-5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01457339     History of Changes
Other Study ID Numbers: SPD489-119
First Submitted: October 19, 2011
First Posted: October 21, 2011
Results First Submitted: December 13, 2012
Results First Posted: January 21, 2013
Last Update Posted: March 23, 2015