Trial Outcomes & Findings for SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study (NCT NCT01436175)
NCT ID: NCT01436175
Last Updated: 2021-06-14
Results Overview
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.
TERMINATED
PHASE3
1570 participants
Week 5 up to Week 52/Early Termination(ET)
2021-06-14
Participant Flow
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 \[NCT01436162\]).
Participant milestones
| Measure |
SPD489 + Antidepressant
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.
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|---|---|
|
Overall Study
STARTED
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1570
|
|
Overall Study
COMPLETED
|
300
|
|
Overall Study
NOT COMPLETED
|
1270
|
Reasons for withdrawal
| Measure |
SPD489 + Antidepressant
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 Study
Adverse Event
|
111
|
|
Overall Study
Protocol Violation
|
49
|
|
Overall Study
Withdrawal by Subject
|
108
|
|
Overall Study
Lost to Follow-up
|
89
|
|
Overall Study
Lack of Efficacy
|
24
|
|
Overall Study
Met blood pressure or pulse withdrawal
|
63
|
|
Overall Study
Other
|
826
|
Baseline Characteristics
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
Baseline characteristics by cohort
| Measure |
SPD489 + Antidepressant
n=1559 Participants
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.
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|---|---|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
|
Age, Customized
18-55 Years
|
1333 Participants
n=5 Participants
|
|
Age, Customized
56-65 Years
|
226 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1056 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
503 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1190 Participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 5 up to Week 52/Early Termination(ET)Population: 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
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1559 Participants
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.
|
|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Positive Suicidal Ideation
|
68 participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Attempt
|
4 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52/ETPopulation: Safety Analysis Set. Here n = participants evaluable at specified time-points.
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1559 Participants
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.
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 52
Baseline (n = 1559)
|
117.6 millimeter of mercury(mmHg)
Standard Deviation 11.13
|
|
Change From Baseline in Systolic Blood Pressure at Week 52
Change at Week 52/ET (n = 1558)
|
2.4 millimeter of mercury(mmHg)
Standard Deviation 10.37
|
PRIMARY outcome
Timeframe: Baseline, Week 52/ETPopulation: Safety Analysis Set. Here n = participants evaluable at specified time-points.
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1559 Participants
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.
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|---|---|
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Change From Baseline in Diastolic Blood Pressure at Week 52
Change at Week 52/ET (n = 1558)
|
1.2 mmHg
Standard Deviation 7.94
|
|
Change From Baseline in Diastolic Blood Pressure at Week 52
Baseline (n = 1559)
|
75.4 mmHg
Standard Deviation 8.15
|
PRIMARY outcome
Timeframe: Baseline, Week 52/ETPopulation: Safety Analysis Set. Here n = participants evaluable at specified time-points.
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1559 Participants
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.
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|---|---|
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Change From Baseline in Pulse Rate at Week 52
Baseline (n = 1559)
|
72.7 beats per minute(bpm)
Standard Deviation 9.90
|
|
Change From Baseline in Pulse Rate at Week 52
Change at Week 52/ET (n = 1558)
|
5.2 beats per minute(bpm)
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: Baseline, Week 52/ETPopulation: 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.
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 \[NCT01436162\]).
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1556 Participants
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.
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|---|---|
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
Baseline (n=1548)
|
12.7 units on a scale
Standard Deviation 7.06
|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
Change at Week 52/ET (n = 1530)
|
-4.3 units on a scale
Standard Deviation 7.77
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1345 Participants
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.
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|---|---|
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Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
|
1021 participants
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1531 Participants
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.
|
|---|---|
|
Short Form-12 Health Survey Version 2 (SF-12V2)
Aggregate Physical
|
49.1 units on a scale
Standard Deviation 9.67
|
|
Short Form-12 Health Survey Version 2 (SF-12V2)
Aggregate Mental
|
42.7 units on a scale
Standard Deviation 11.55
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1537 Participants
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.
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|---|---|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
No problems in walking about
|
1193 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Slight problems in walking about
|
237 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Moderate problems in walking about
|
82 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Severe problems in walking about
|
24 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Unable to walk about
|
1 participants
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1537 Participants
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.
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|---|---|
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
No problems washing or dressing myself
|
1304 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Slight problems washing or dressing myself
|
174 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Moderate problems washing or dressing myself
|
49 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Severe problems washing or dressing myself
|
9 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Unable to wash or dress myself
|
1 participants
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1537 Participants
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.
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|---|---|
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
No problems doing my usual activities
|
800 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Slight problems doing my usual activities
|
475 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Moderate problems doing my usual activities
|
197 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Severe problems doing my usual activities
|
55 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Unable to do my usual activities
|
10 participants
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1537 Participants
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.
|
|---|---|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
No pain or discomfort
|
715 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Slight pain or discomfort
|
536 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Moderate pain or discomfort
|
208 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Severe pain or discomfort
|
68 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Extreme pain or discomfort
|
10 participants
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1537 Participants
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.
|
|---|---|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Not anxious or depressed
|
461 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Slightly anxious or depressed
|
687 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Moderately anxious or depressed
|
289 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Severely anxious or depressed
|
73 participants
|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Extremely anxious or depressed
|
27 participants
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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
Outcome measures
| Measure |
SPD489 + Antidepressant
n=1537 Participants
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.
|
|---|---|
|
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale
|
75.7 units on a scale
Standard Deviation 18.35
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=506 Participants
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.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
|
6.9 units on a scale
Standard Deviation 4.48
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=506 Participants
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.
|
|---|---|
|
Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Summary Scale (n = 506)
|
61.5 units on a scale
Standard Deviation 17.22
|
|
Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Satisfaction with Medication (n = 478)
|
68.6 units on a scale
Standard Deviation 19.66
|
|
Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Overall Satisfaction and Contentment (n = 506)
|
63.2 units on a scale
Standard Deviation 21.58
|
SECONDARY outcome
Timeframe: Baseline, Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.
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 \[NCT01436162\]).
Outcome measures
| Measure |
SPD489 + Antidepressant
n=508 Participants
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.
|
|---|---|
|
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
Male: Baseline (n=167)
|
46.6 units on a scale
Standard Deviation 9.17
|
|
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
Male: Change at Week 52/ET (n=164)
|
1.7 units on a scale
Standard Deviation 7.16
|
|
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
Female: Baseline (n=341)
|
37.2 units on a scale
Standard Deviation 9.65
|
|
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
Female: Change at Week 52/ET (n=330)
|
2.8 units on a scale
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Week 53Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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 |
SPD489 + Antidepressant
n=1349 Participants
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.
|
|---|---|
|
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
|
14.3 units on a scale
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=482 Participants
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.
|
|---|---|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Past Week Was Typical: Yes
|
249 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Past Week Was Typical: No, Worked More Hours
|
43 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Past Week Was Typical: No, Worked Less Hours
|
45 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Volunteer Work
|
86 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason no Money/VW: Physically Ill
|
6 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason no Money/VW: Upset/Depressed/Nervous
|
30 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason no Money/VW: Cannot Find Work
|
39 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason no Money/VW: Other
|
48 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason no Money/VW: Not Applicable
|
348 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Hospitalized in Past Month
|
4 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Work for Pay
|
337 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason Missing Work Time: Had a Day Off
|
24 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason Missing Work Time: Physically Ill
|
10 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason Missing Work Time: Upset/Depressed/Nervous
|
15 participants
|
|
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Reason Missing Work Time: Other
|
36 participants
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=482 Participants
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.
|
|---|---|
|
PRUQ-MDD - Number of Days of Resource Utilization
Number of nights in medical/surgical ward (n=4)
|
1.3 days
Standard Deviation 0.50
|
|
PRUQ-MDD - Number of Days of Resource Utilization
Number of nights in ICU (n=4)
|
0.0 days
Standard Deviation 0.00
|
|
PRUQ-MDD - Number of Days of Resource Utilization
Number of days received home care in past month
|
0.0 days
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=482 Participants
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.
|
|---|---|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Visit to Family doctor/primary care (n=481)
|
0.2 events
Standard Deviation 0.58
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Visit to NPHP(n=480)
|
0.1 events
Standard Deviation 0.43
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Visit to PPC(n=481)
|
0.1 events
Standard Deviation 0.86
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Test performed: Blood Test (n=480)
|
0.2 events
Standard Deviation 2.30
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Test performed: CT Scan (n=480)
|
0.0 events
Standard Deviation 0.08
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Test performed: X Ray (n=480)
|
0.0 events
Standard Deviation 0.20
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Test performed: Renal function (n=480)
|
0.0 events
Standard Deviation 0.00
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Test performed: Thyroid function (n=480)
|
0.0 events
Standard Deviation 0.09
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Test performed: Other test (n=479)
|
0.1 events
Standard Deviation 0.49
|
|
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Visit to Hospital ER, UCF or AHC (n=482)
|
0.0 events
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=482 Participants
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.
|
|---|---|
|
PRUQ-MDD - Number of Hours
Work or usually expect to work (n=337)
|
34.0 hours
Standard Deviation 11.85
|
|
PRUQ-MDD - Number of Hours
Actual work (n=337)
|
31.2 hours
Standard Deviation 15.13
|
|
PRUQ-MDD - Number of Hours
Average volunteer per week (n=86)
|
8.6 hours
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: Week 52/ETPopulation: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
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.
Outcome measures
| Measure |
SPD489 + Antidepressant
n=482 Participants
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.
|
|---|---|
|
PRUQ-MDD - Effect of Depressive Symptoms
Affected work productivity (n= 335)
|
2.1 units on scale
Standard Deviation 2.37
|
|
PRUQ-MDD - Effect of Depressive Symptoms
Affected regular non work daily activities (n=482)
|
2.5 units on scale
Standard Deviation 2.43
|
Adverse Events
SPD489 + Antidepressant
Serious adverse events
| Measure |
SPD489 + Antidepressant
n=1559 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
General disorders
Chest pain
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
General disorders
Non-Cardiac chest pain
|
0.13%
2/1559 • Number of events 2 • Up to Week 53
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.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Infections and infestations
Influenza
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Infections and infestations
Pneumonia
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Infections and infestations
Urinary tract infection
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Investigations
Blood pressure increased
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Nervous system disorders
Ischaemic stroke
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Nervous system disorders
Migraine
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Psychiatric disorders
Depression
|
0.13%
2/1559 • Number of events 2 • Up to Week 53
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.
|
|
Psychiatric disorders
Depressive symptom
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Psychiatric disorders
Major depression
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Psychiatric disorders
Psychotic disorder
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Psychiatric disorders
Suicidal ideation
|
0.19%
3/1559 • Number of events 3 • Up to Week 53
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.
|
|
Psychiatric disorders
Suicide attempt
|
0.19%
3/1559 • Number of events 3 • Up to Week 53
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.
|
|
Renal and urinary disorders
Renal cyst
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Renal and urinary disorders
Renal mass
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.06%
1/1559 • Number of events 1 • Up to Week 53
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
2/1559 • Number of events 2 • Up to Week 53
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.
|
Other adverse events
| Measure |
SPD489 + Antidepressant
n=1559 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
13.6%
212/1559 • Number of events 233 • Up to Week 53
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.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
116/1559 • Number of events 132 • Up to Week 53
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.
|
|
General disorders
Fatigue
|
5.1%
80/1559 • Number of events 82 • Up to Week 53
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.
|
|
General disorders
Feeling jittery
|
5.3%
82/1559 • Number of events 89 • Up to Week 53
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.
|
|
General disorders
Irritability
|
5.1%
79/1559 • Number of events 87 • Up to Week 53
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.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
137/1559 • Number of events 156 • Up to Week 53
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
100/1559 • Number of events 117 • Up to Week 53
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.1%
189/1559 • Number of events 210 • Up to Week 53
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.
|
|
Nervous system disorders
Dizziness
|
5.8%
91/1559 • Number of events 102 • Up to Week 53
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.
|
|
Nervous system disorders
Headache
|
15.5%
241/1559 • Number of events 347 • Up to Week 53
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.
|
|
Psychiatric disorders
Anxiety
|
5.3%
83/1559 • Number of events 94 • Up to Week 53
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.
|
|
Psychiatric disorders
Bruxism
|
5.7%
89/1559 • Number of events 97 • Up to Week 53
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.
|
|
Psychiatric disorders
Insomnia
|
13.1%
204/1559 • Number of events 235 • Up to Week 53
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER