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Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01436149
Recruitment Status : Completed
First Posted : September 19, 2011
Results First Posted : November 19, 2014
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: SPD489 (Lisdexamfetamine dimesylate )
Drug: Placebo
Enrollment 1262
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antidepressant + Single-blind Placebo Antidepressant + Double-blind Placebo Antidepressant + Double-blind SPD489
Hide Arm/Group Description Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended-release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489). Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489). Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose).
Period Title: Antidepressant Lead-in Phase
Started 1262 [1] 0 0
Completed 896 0 0
Not Completed 366 0 0
Reason Not Completed
Adverse Event             39             0             0
Protocol Violation             29             0             0
Withdrawal by Subject             61             0             0
Lost to Follow-up             96             0             0
Met BP Or Pulse Withdrawal Criteria             22             0             0
Not Specified             119             0             0
[1]
Twenty-three subjects were enrolled but not dosed.
Period Title: Randomized Phase
Started 492 [1] 202 [2] 202 [2]
Completed 415 164 160 [3]
Not Completed 77 38 42
Reason Not Completed
Adverse Event             9             10             11
Protocol Violation             4             5             0
Withdrawal by Subject             16             10             10
Lost to Follow-up             34             5             6
Lack of Efficacy             0             0             1
Met BP Or Pulse Withdrawal Criteria             2             3             3
Not Specified             12             5             11
[1]
These subjects were not included in the Safety Analysis Set or Full Analysis Set.
[2]
One subject did not receive at least 1 dose of double-blind treatment.
[3]
1 subject completed the study without a Visit 14 MADRS and was not included in the completers set.
Arm/Group Title Antidepressant + Double-blind Placebo Antidepressant + Double-blind SPD489 Total
Hide Arm/Group Description Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks. Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose) for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 201 201 402
Hide Baseline Analysis Population Description
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an adverse event [AE], or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 201 participants 402 participants
41.8  (12.04) 42.2  (12.32) 42  (12.17)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 201 participants 201 participants 402 participants
18-55 years 173 170 343
56-65 years 28 31 59
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 201 participants 402 participants
Female
133
  66.2%
129
  64.2%
262
  65.2%
Male
68
  33.8%
72
  35.8%
140
  34.8%
1.Primary Outcome
Title Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks
Hide Description MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 200 200
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-6.3
(-7.6 to -4.9)
-6.1
(-7.5 to -4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + Placebo, Antidepressant + SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments [Not Specified]
Method Mixed- effects Model for Repeat Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-1.7 to 2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.96
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks
Hide Description Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 200 200
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.3
(-5.3 to -3.3)
-4.7
(-5.6 to -3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + Placebo, Antidepressant + SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments [Not Specified]
Method Mixed- effects Model for Repeat Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.8 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving a 25% Response on the MADRS
Hide Description The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET).
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 200 200
Measure Type: Number
Unit of Measure: percentage of participants
65.0 74.5
4.Secondary Outcome
Title Percentage of Participants Achieving a 50% Response on the MADRS
Hide Description The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET).
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 200 200
Measure Type: Number
Unit of Measure: percentage of participants
38.5 41.0
5.Secondary Outcome
Title Percentage of Participants Achieving Remission on the MADRS
Hide Description MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET).
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 200 200
Measure Type: Number
Unit of Measure: percentage of participants
22.5 18.5
6.Secondary Outcome
Title Mean Change From Baseline Over Time in MADRS Total Score
Hide Description MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame Baseline and up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 200 200
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Visit 9 (Week 9)
-2.2
(-3.1 to -1.2)
-3.4
(-4.3 to -2.4)
Visit 10 (Week 10)
-3.8
(-4.9 to -2.7)
-4.2
(-5.3 to -3.2)
Visit 11 (Week 11)
-6.0
(-7.2 to -4.8)
-5.4
(-6.6 to -4.2)
Visit 12 (Week 12)
-6.2
(-7.4 to -5.0)
-5.6
(-6.8 to -4.4)
Visit 13 (Week 14)
-7.4
(-8.7 to -6.0)
-7.3
(-8.6 to -6.0)
Visit 14 (Week 16)
-6.3
(-7.6 to -4.9)
-6.1
(-7.5 to -4.8)
7.Secondary Outcome
Title Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)
Hide Description The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms.
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 186 185
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.6
(-3.2 to -1.9)
-2.3
(-2.9 to -1.7)
8.Secondary Outcome
Title Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)
Hide Description Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 189 186
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Physical
0.69
(-0.39 to 1.77)
-0.81
(-1.89 to 0.28)
Mental
5.59
(3.93 to 7.25)
6.5
(4.84 to 8.16)
9.Secondary Outcome
Title Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Hide Description The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life.
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 188 184
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.2
(4.9 to 9.5)
7.0
(4.7 to 9.3)
10.Secondary Outcome
Title Clinical Global Impressions - Global Improvement (CGI-I)
Hide Description Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 199 199
Measure Type: Number
Unit of Measure: percentage of participants
Improved 53.3 55.3
Not Improved 46.2 44.7
Not Assessed 0.5 0
11.Secondary 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 behaviors 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 behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 201 201
Measure Type: Number
Unit of Measure: percentage of participants
≥1 postive suicidal ideation 7.0 7.0
≥1 suicidal attempt 0.5 0
12.Secondary Outcome
Title Amphetamine Cessation Symptom Assessment (ACSA)
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 up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description:
Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
Overall Number of Participants Analyzed 178 183
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.1  (10.71) 14.7  (10.94)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antidepressant + Placebo Antidepressant + SPD489
Hide Arm/Group Description Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489). Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50 or 70 mg dose).
All-Cause Mortality
Antidepressant + Placebo Antidepressant + SPD489
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Antidepressant + Placebo Antidepressant + SPD489
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/201 (2.49%)      3/201 (1.49%)    
Ear and labyrinth disorders     
Vertigo  1/201 (0.50%)  1 0/201 (0.00%)  0
Infections and infestations     
Appendicitis  0/201 (0.00%)  0 1/201 (0.50%)  1
Wound infection  1/201 (0.50%)  1 0/201 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose  0/201 (0.00%)  0 1/201 (0.50%)  1
Laceration  1/201 (0.50%)  1 0/201 (0.00%)  0
Nervous system disorders     
Syncope  1/201 (0.50%)  1 1/201 (0.50%)  1
Psychiatric disorders     
Major depression  1/201 (0.50%)  1 0/201 (0.00%)  0
Suicide attempt  1/201 (0.50%)  1 0/201 (0.00%)  0
Surgical and medical procedures     
Appendicectomy  1/201 (0.50%)  1 0/201 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antidepressant + Placebo Antidepressant + SPD489
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/201 (26.87%)      70/201 (34.83%)    
Gastrointestinal disorders     
Dry mouth  6/201 (2.99%)  6 19/201 (9.45%)  19
Nausea  10/201 (4.98%)  11 13/201 (6.47%)  13
Infections and infestations     
Nasopharyngitis  4/201 (1.99%)  4 11/201 (5.47%)  12
Metabolism and nutrition disorders     
Decreased appetite  8/201 (3.98%)  8 15/201 (7.46%)  17
Nervous system disorders     
Headache  21/201 (10.45%)  28 13/201 (6.47%)  14
Psychiatric disorders     
Insomnia  15/201 (7.46%)  16 19/201 (9.45%)  20
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
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01436149     History of Changes
Other Study ID Numbers: SPD489-322
2011-003018-17 ( EudraCT Number )
First Submitted: September 15, 2011
First Posted: September 19, 2011
Results First Submitted: November 10, 2014
Results First Posted: November 19, 2014
Last Update Posted: January 4, 2019