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Trial record 53 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01436175
Recruitment Status : Terminated (SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.)
First Posted : September 19, 2011
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Enrollment 1570
Recruitment Details Study enrolled eligible adults with major depressive disorder (MDD) who had completed treatment in a short-term antecedent SPD489 (lisdexamfetamine dimesylate) MDD study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Pre-assignment Details  
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Period Title: Overall Study
Started 1570
Completed 300
Not Completed 1270
Reason Not Completed
Adverse Event             111
Protocol Violation             49
Withdrawal by Subject             108
Lost to Follow-up             89
Lack of Efficacy             24
Met blood pressure or pulse withdrawal             63
Other             826
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Baseline Participants 1559
Hide Baseline Analysis Population Description
Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1559 participants
41.9  (11.89)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1559 participants
18-55 Years 1333
56-65 Years 226
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1559 participants
Female
1056
  67.7%
Male
503
  32.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1559 participants
United States 1190
Estonia 24
Hungary 4
Czech Republic 83
Mexico 27
Canada 36
Finland 8
Spain 6
Poland 20
Romania 8
South Africa 5
Chile 33
Germany 69
Argentina 27
Australia 13
United Kingdom 1
Croatia 5
1.Primary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Time Frame Week 5 up to Week 52/Early Termination(ET)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1559
Measure Type: Number
Unit of Measure: participants
Positive Suicidal Ideation 68
Suicidal Attempt 4
2.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure at Week 52
Hide Description Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Time Frame Baseline, Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Here n = participants evaluable at specified time-points.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1559
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury(mmHg)
Baseline (n = 1559) 117.6  (11.13)
Change at Week 52/ET (n = 1558) 2.4  (10.37)
3.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Week 52
Hide Description Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Time Frame Baseline, Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Here n = participants evaluable at specified time-points.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1559
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (n = 1559) 75.4  (8.15)
Change at Week 52/ET (n = 1558) 1.2  (7.94)
4.Primary Outcome
Title Change From Baseline in Pulse Rate at Week 52
Hide Description Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Time Frame Baseline, Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. Here n = participants evaluable at specified time-points.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1559
Mean (Standard Deviation)
Unit of Measure: beats per minute(bpm)
Baseline (n = 1559) 72.7  (9.90)
Change at Week 52/ET (n = 1558) 5.2  (10.58)
5.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
Hide Description

Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.

Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).

Time Frame Baseline, Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1556
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1548) 12.7  (7.06)
Change at Week 52/ET (n = 1530) -4.3  (7.77)
6.Secondary Outcome
Title Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
Hide Description Participants who did not have Clinical Global Impressions – Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1345
Measure Type: Number
Unit of Measure: participants
1021
7.Secondary Outcome
Title Short Form-12 Health Survey Version 2 (SF-12V2)
Hide Description SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1531
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aggregate Physical 49.1  (9.67)
Aggregate Mental 42.7  (11.55)
8.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Hide Description Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1537
Measure Type: Number
Unit of Measure: participants
No problems in walking about 1193
Slight problems in walking about 237
Moderate problems in walking about 82
Severe problems in walking about 24
Unable to walk about 1
9.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Hide Description Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1537
Measure Type: Number
Unit of Measure: participants
No problems washing or dressing myself 1304
Slight problems washing or dressing myself 174
Moderate problems washing or dressing myself 49
Severe problems washing or dressing myself 9
Unable to wash or dress myself 1
10.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Hide Description Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1537
Measure Type: Number
Unit of Measure: participants
No problems doing my usual activities 800
Slight problems doing my usual activities 475
Moderate problems doing my usual activities 197
Severe problems doing my usual activities 55
Unable to do my usual activities 10
11.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Hide Description Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1537
Measure Type: Number
Unit of Measure: participants
No pain or discomfort 715
Slight pain or discomfort 536
Moderate pain or discomfort 208
Severe pain or discomfort 68
Extreme pain or discomfort 10
12.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Hide Description Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1537
Measure Type: Number
Unit of Measure: participants
Not anxious or depressed 461
Slightly anxious or depressed 687
Moderately anxious or depressed 289
Severely anxious or depressed 73
Extremely anxious or depressed 27
13.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale
Hide Description EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1537
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.7  (18.35)
14.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Hide Description QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 (Lisdexamfetamine dimesylate) + Antidepressant: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
Overall Number of Participants Analyzed 506
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.9  (4.48)
15.Secondary Outcome
Title Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Hide Description The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 506
Mean (Standard Deviation)
Unit of Measure: units on a scale
Summary Scale (n = 506) 61.5  (17.22)
Satisfaction with Medication (n = 478) 68.6  (19.66)
Overall Satisfaction and Contentment (n = 506) 63.2  (21.58)
16.Secondary Outcome
Title Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
Hide Description CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).
Time Frame Baseline, Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 508
Mean (Standard Deviation)
Unit of Measure: units on a scale
Male: Baseline (n=167) 46.6  (9.17)
Male: Change at Week 52/ET (n=164) 1.7  (7.16)
Female: Baseline (n=341) 37.2  (9.65)
Female: Change at Week 52/ET (n=330) 2.8  (8.33)
17.Secondary Outcome
Title Amphetamine Cessation Symptom Assessment (ACSA) Total Score
Hide Description ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Time Frame Week 53
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 1349
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.3  (10.59)
18.Secondary Outcome
Title Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Hide Description

The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions:

1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is.

Number of participants with response is reported.

Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 482
Measure Type: Number
Unit of Measure: participants
Hospitalized in Past Month 4
Work for Pay 337
Reason Missing Work Time: Had a Day Off 24
Reason Missing Work Time: Physically Ill 10
Reason Missing Work Time: Upset/Depressed/Nervous 15
Reason Missing Work Time: Other 36
Past Week Was Typical: Yes 249
Past Week Was Typical: No, Worked More Hours 43
Past Week Was Typical: No, Worked Less Hours 45
Volunteer Work 86
Reason no Money/VW: Physically Ill 6
Reason no Money/VW: Upset/Depressed/Nervous 30
Reason no Money/VW: Cannot Find Work 39
Reason no Money/VW: Other 48
Reason no Money/VW: Not Applicable 348
19.Secondary Outcome
Title PRUQ-MDD – Number of Days of Resource Utilization
Hide Description The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 482
Mean (Standard Deviation)
Unit of Measure: days
Number of nights in medical/surgical ward (n=4) 1.3  (0.50)
Number of nights in ICU (n=4) 0.0  (0.00)
Number of days received home care in past month 0.0  (0.00)
20.Secondary Outcome
Title PRUQ-MDD – Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Hide Description The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions – 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 482
Mean (Standard Deviation)
Unit of Measure: events
Visit to Family doctor/primary care (n=481) 0.2  (0.58)
Visit to NPHP(n=480) 0.1  (0.43)
Visit to PPC(n=481) 0.1  (0.86)
Test performed: Blood Test (n=480) 0.2  (2.30)
Test performed: CT Scan (n=480) 0.0  (0.08)
Test performed: X Ray (n=480) 0.0  (0.20)
Test performed: Renal function (n=480) 0.0  (0.00)
Test performed: Thyroid function (n=480) 0.0  (0.09)
Test performed: Other test (n=479) 0.1  (0.49)
Visit to Hospital ER, UCF or AHC (n=482) 0.0  (0.23)
21.Secondary Outcome
Title PRUQ-MDD – Number of Hours
Hide Description The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.
Time Frame Week 52/ET
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Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 482
Mean (Standard Deviation)
Unit of Measure: hours
Work or usually expect to work (n=337) 34.0  (11.85)
Actual work (n=337) 31.2  (15.13)
Average volunteer per week (n=86) 8.6  (8.94)
22.Secondary Outcome
Title PRUQ-MDD – Effect of Depressive Symptoms
Hide Description The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale – 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.
Time Frame Week 52/ET
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description:
SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
Overall Number of Participants Analyzed 482
Mean (Standard Deviation)
Unit of Measure: units on scale
Affected work productivity (n= 335) 2.1  (2.37)
Affected regular non work daily activities (n=482) 2.5  (2.43)
Time Frame Up to Week 53
Adverse Event Reporting Description Treatment-Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or deteriorated on or after the date of the first dose of investigational product and no later than 3 days after the last dose of investigational product.
 
Arm/Group Title SPD489 + Antidepressant
Hide Arm/Group Description SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
All-Cause Mortality
SPD489 + Antidepressant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SPD489 + Antidepressant
Affected / at Risk (%) # Events
Total   33/1559 (2.12%)    
Cardiac disorders   
Angina pectoris * 1  1/1559 (0.06%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/1559 (0.06%)  1
Intestinal strangulation * 1  1/1559 (0.06%)  1
Small intestinal obstruction * 1  1/1559 (0.06%)  1
General disorders   
Chest pain * 1  1/1559 (0.06%)  1
Non-Cardiac chest pain * 1  2/1559 (0.13%)  2
Hepatobiliary disorders   
Cholecystitis acute * 1  1/1559 (0.06%)  1
Infections and infestations   
Appendicitis * 1  1/1559 (0.06%)  1
Influenza * 1  1/1559 (0.06%)  1
Pneumonia * 1  1/1559 (0.06%)  1
Urinary tract infection * 1  1/1559 (0.06%)  1
Injury, poisoning and procedural complications   
Gun shot wound * 1  1/1559 (0.06%)  1
Head injury * 1  1/1559 (0.06%)  1
Radius fracture * 1  1/1559 (0.06%)  1
Road traffic accident * 1  1/1559 (0.06%)  1
Investigations   
Blood pressure increased * 1  1/1559 (0.06%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/1559 (0.06%)  1
Costochondritis * 1  1/1559 (0.06%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Angiomyolipoma * 1  1/1559 (0.06%)  1
Ovarian fibroma * 1  1/1559 (0.06%)  1
Nervous system disorders   
Ischaemic stroke * 1  1/1559 (0.06%)  1
Migraine * 1  1/1559 (0.06%)  1
Transient ischaemic attack * 1  1/1559 (0.06%)  1
Psychiatric disorders   
Depression * 1  2/1559 (0.13%)  2
Depressive symptom * 1  1/1559 (0.06%)  1
Hallucination, auditory * 1  1/1559 (0.06%)  1
Major depression * 1  1/1559 (0.06%)  1
Psychotic disorder * 1  1/1559 (0.06%)  1
Suicidal ideation * 1  3/1559 (0.19%)  3
Suicide attempt * 1  3/1559 (0.19%)  3
Renal and urinary disorders   
Renal cyst * 1  1/1559 (0.06%)  1
Renal mass * 1  1/1559 (0.06%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/1559 (0.06%)  1
Epistaxis * 1  1/1559 (0.06%)  1
Hypoxia * 1  1/1559 (0.06%)  1
Pneumomediastinum * 1  1/1559 (0.06%)  1
Pneumonia aspiration * 1  1/1559 (0.06%)  1
Respiratory arrest * 1  1/1559 (0.06%)  1
Vascular disorders   
Deep vein thrombosis * 1  2/1559 (0.13%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPD489 + Antidepressant
Affected / at Risk (%) # Events
Total   921/1559 (59.08%)    
Gastrointestinal disorders   
Dry mouth * 1  212/1559 (13.60%)  233
Nausea * 1  116/1559 (7.44%)  132
General disorders   
Fatigue * 1  80/1559 (5.13%)  82
Feeling jittery * 1  82/1559 (5.26%)  89
Irritability * 1  79/1559 (5.07%)  87
Infections and infestations   
Nasopharyngitis * 1  137/1559 (8.79%)  156
Upper respiratory tract infection * 1  100/1559 (6.41%)  117
Metabolism and nutrition disorders   
Decreased appetite * 1  189/1559 (12.12%)  210
Nervous system disorders   
Dizziness * 1  91/1559 (5.84%)  102
Headache * 1  241/1559 (15.46%)  347
Psychiatric disorders   
Anxiety * 1  83/1559 (5.32%)  94
Bruxism * 1  89/1559 (5.71%)  97
Insomnia * 1  204/1559 (13.09%)  235
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
The study was terminated on 11 Feb 2014. SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.
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 multi-centre 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 multi-centre 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
Phone: 1 866-842-5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01436175     History of Changes
Other Study ID Numbers: SPD489-329
2011-003019-47 ( EudraCT Number )
First Submitted: September 15, 2011
First Posted: September 19, 2011
Results First Submitted: February 5, 2015
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015