Trial Outcomes & Findings for Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder (NCT NCT01436149)
NCT ID: NCT01436149
Last Updated: 2021-06-09
Results Overview
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.
COMPLETED
PHASE3
1262 participants
8 weeks
2021-06-09
Participant Flow
Participant milestones
| Measure |
Antidepressant + Single-blind Placebo
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).
|
Antidepressant + Double-blind Placebo
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).
|
Antidepressant + Double-blind 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).
|
|---|---|---|---|
|
Antidepressant Lead-in Phase
STARTED
|
1262
|
0
|
0
|
|
Antidepressant Lead-in Phase
COMPLETED
|
896
|
0
|
0
|
|
Antidepressant Lead-in Phase
NOT COMPLETED
|
366
|
0
|
0
|
|
Randomized Phase
STARTED
|
492
|
202
|
202
|
|
Randomized Phase
COMPLETED
|
415
|
164
|
160
|
|
Randomized Phase
NOT COMPLETED
|
77
|
38
|
42
|
Reasons for withdrawal
| Measure |
Antidepressant + Single-blind Placebo
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).
|
Antidepressant + Double-blind Placebo
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).
|
Antidepressant + Double-blind 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).
|
|---|---|---|---|
|
Antidepressant Lead-in Phase
Adverse Event
|
39
|
0
|
0
|
|
Antidepressant Lead-in Phase
Protocol Violation
|
29
|
0
|
0
|
|
Antidepressant Lead-in Phase
Withdrawal by Subject
|
61
|
0
|
0
|
|
Antidepressant Lead-in Phase
Lost to Follow-up
|
96
|
0
|
0
|
|
Antidepressant Lead-in Phase
Met BP Or Pulse Withdrawal Criteria
|
22
|
0
|
0
|
|
Antidepressant Lead-in Phase
Other
|
119
|
0
|
0
|
|
Randomized Phase
Adverse Event
|
9
|
10
|
11
|
|
Randomized Phase
Protocol Violation
|
4
|
5
|
0
|
|
Randomized Phase
Withdrawal by Subject
|
16
|
10
|
10
|
|
Randomized Phase
Lost to Follow-up
|
34
|
5
|
6
|
|
Randomized Phase
Lack of Efficacy
|
0
|
0
|
1
|
|
Randomized Phase
Met BP Or Pulse Withdrawal Criteria
|
2
|
3
|
3
|
|
Randomized Phase
Other
|
12
|
5
|
11
|
Baseline Characteristics
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Antidepressant + Double-blind Placebo
n=201 Participants
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.
|
Antidepressant + Double-blind SPD489
n=201 Participants
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
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 Years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
42.2 Years
STANDARD_DEVIATION 12.32 • n=7 Participants
|
42 Years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
|
Age, Customized
18-55 years
|
173 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Age, Customized
56-65 years
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=200 Participants
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
n=200 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks
|
-6.3 units on a scale
Interval -7.6 to -4.9
|
-6.1 units on a scale
Interval -7.5 to -4.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=200 Participants
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
n=200 Participants
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.
|
|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks
|
-4.3 units on a scale
Interval -5.3 to -3.3
|
-4.7 units on a scale
Interval -5.6 to -3.7
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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).
Outcome measures
| Measure |
Antidepressant + Placebo
n=200 Participants
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
n=200 Participants
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.
|
|---|---|---|
|
Percentage of Participants Achieving a 25% Response on the MADRS
|
65.0 percentage of participants
|
74.5 percentage of participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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).
Outcome measures
| Measure |
Antidepressant + Placebo
n=200 Participants
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
n=200 Participants
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.
|
|---|---|---|
|
Percentage of Participants Achieving a 50% Response on the MADRS
|
38.5 percentage of participants
|
41.0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET).
Outcome measures
| Measure |
Antidepressant + Placebo
n=200 Participants
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
n=200 Participants
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.
|
|---|---|---|
|
Percentage of Participants Achieving Remission on the MADRS
|
22.5 percentage of participants
|
18.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=200 Participants
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
n=200 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline Over Time in MADRS Total Score
Visit 9 (Week 9)
|
-2.2 units on a scale
Interval -3.1 to -1.2
|
-3.4 units on a scale
Interval -4.3 to -2.4
|
|
Mean Change From Baseline Over Time in MADRS Total Score
Visit 10 (Week 10)
|
-3.8 units on a scale
Interval -4.9 to -2.7
|
-4.2 units on a scale
Interval -5.3 to -3.2
|
|
Mean Change From Baseline Over Time in MADRS Total Score
Visit 11 (Week 11)
|
-6.0 units on a scale
Interval -7.2 to -4.8
|
-5.4 units on a scale
Interval -6.6 to -4.2
|
|
Mean Change From Baseline Over Time in MADRS Total Score
Visit 12 (Week 12)
|
-6.2 units on a scale
Interval -7.4 to -5.0
|
-5.6 units on a scale
Interval -6.8 to -4.4
|
|
Mean Change From Baseline Over Time in MADRS Total Score
Visit 13 (Week 14)
|
-7.4 units on a scale
Interval -8.7 to -6.0
|
-7.3 units on a scale
Interval -8.6 to -6.0
|
|
Mean Change From Baseline Over Time in MADRS Total Score
Visit 14 (Week 16)
|
-6.3 units on a scale
Interval -7.6 to -4.9
|
-6.1 units on a scale
Interval -7.5 to -4.8
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=186 Participants
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
n=185 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)
|
-2.6 units on a scale
Interval -3.2 to -1.9
|
-2.3 units on a scale
Interval -2.9 to -1.7
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=189 Participants
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
n=186 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)
Physical
|
0.69 units on a scale
Interval -0.39 to 1.77
|
-0.81 units on a scale
Interval -1.89 to 0.28
|
|
Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)
Mental
|
5.59 units on a scale
Interval 3.93 to 7.25
|
6.5 units on a scale
Interval 4.84 to 8.16
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=188 Participants
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
n=184 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
|
7.2 units on a scale
Interval 4.9 to 9.5
|
7.0 units on a scale
Interval 4.7 to 9.3
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=199 Participants
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
n=199 Participants
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.
|
|---|---|---|
|
Clinical Global Impressions - Global Improvement (CGI-I)
Improved
|
53.3 percentage of participants
|
55.3 percentage of participants
|
|
Clinical Global Impressions - Global Improvement (CGI-I)
Not Improved
|
46.2 percentage of participants
|
44.7 percentage of participants
|
|
Clinical Global Impressions - Global Improvement (CGI-I)
Not Assessed
|
0.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=201 Participants
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
n=201 Participants
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.
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
≥1 postive suicidal ideation
|
7.0 percentage of participants
|
7.0 percentage of participants
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
≥1 suicidal attempt
|
0.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Antidepressant + Placebo
n=178 Participants
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
n=183 Participants
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.
|
|---|---|---|
|
Amphetamine Cessation Symptom Assessment (ACSA)
|
15.1 units on a scale
Standard Deviation 10.71
|
14.7 units on a scale
Standard Deviation 10.94
|
Adverse Events
Antidepressant + Placebo
Antidepressant + SPD489
Serious adverse events
| Measure |
Antidepressant + Placebo
n=201 participants at risk
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).
|
Antidepressant + SPD489
n=201 participants at risk
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).
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
1/201 • Number of events 1
|
0.00%
0/201
|
|
Infections and infestations
Appendicitis
|
0.00%
0/201
|
0.50%
1/201 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.50%
1/201 • Number of events 1
|
0.00%
0/201
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/201
|
0.50%
1/201 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.50%
1/201 • Number of events 1
|
0.00%
0/201
|
|
Nervous system disorders
Syncope
|
0.50%
1/201 • Number of events 1
|
0.50%
1/201 • Number of events 1
|
|
Psychiatric disorders
Major depression
|
0.50%
1/201 • Number of events 1
|
0.00%
0/201
|
|
Psychiatric disorders
Suicide attempt
|
0.50%
1/201 • Number of events 1
|
0.00%
0/201
|
|
Surgical and medical procedures
Appendicectomy
|
0.50%
1/201 • Number of events 1
|
0.00%
0/201
|
Other adverse events
| Measure |
Antidepressant + Placebo
n=201 participants at risk
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).
|
Antidepressant + SPD489
n=201 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
3.0%
6/201 • Number of events 6
|
9.5%
19/201 • Number of events 19
|
|
Gastrointestinal disorders
Nausea
|
5.0%
10/201 • Number of events 11
|
6.5%
13/201 • Number of events 13
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
4/201 • Number of events 4
|
5.5%
11/201 • Number of events 12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
8/201 • Number of events 8
|
7.5%
15/201 • Number of events 17
|
|
Nervous system disorders
Headache
|
10.4%
21/201 • Number of events 28
|
6.5%
13/201 • Number of events 14
|
|
Psychiatric disorders
Insomnia
|
7.5%
15/201 • Number of events 16
|
9.5%
19/201 • Number of events 20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER