Trial Outcomes & Findings for Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression (NCT NCT00531947)
NCT ID: NCT00531947
Last Updated: 2014-01-15
Results Overview
A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time. CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior.
COMPLETED
PHASE4
308 participants
baseline and 12 Weeks
2014-01-15
Participant Flow
Male and female adolescent subjects between 12 to 17 years of age diagnosed with moderate to severe major depressive disorder were screened over an approximate two year period at 26 investigative sites in the U.S.
Participant milestones
| Measure |
Placebo
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Overall Study
STARTED
|
156
|
152
|
|
Overall Study
COMPLETED
|
114
|
101
|
|
Overall Study
NOT COMPLETED
|
42
|
51
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
10
|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
|
Overall Study
Withdrawal by Subject
|
14
|
19
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Non-Compliance
|
4
|
7
|
|
Overall Study
Other (e.g., Lack of Efficacy)
|
5
|
5
|
Baseline Characteristics
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Baseline characteristics by cohort
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
156 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.7 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
14.8 years
STANDARD_DEVIATION 1.62 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 1.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
77 participants
n=5 Participants
|
69 participants
n=7 Participants
|
146 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
34 participants
n=5 Participants
|
46 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
37 participants
n=5 Participants
|
32 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 WeeksPopulation: Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).
A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time. CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=150 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
Baseline - Observed
|
57.9 units on a scale
Standard Deviation 12.57
|
56.7 units on a scale
Standard Deviation 12.34
|
|
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
Week 12 - Observed
|
36.4 units on a scale
Standard Deviation 15.91
|
35.4 units on a scale
Standard Deviation 15.30
|
|
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
Week 12 - Change From Baseline
|
-21.5 units on a scale
Standard Deviation 16.47
|
-21.4 units on a scale
Standard Deviation 16.61
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).
A summary of the Clinical Global Impression of Severity (CGI-S) at baseline and Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-s is the clinician's assessment of severity of illness (depression). Scores range from 1(minimum) to 7(maximum). A lower score indicates lower illness severity, a higher score indicates higher levels of illness severity.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=150 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CGI-S - Week 12 (mITT w/LOCF Population)
Baseline CGI-S Scale
|
4.494 units on a scale
Standard Deviation 0.659
|
4.527 units on a scale
Standard Deviation 0.662
|
|
CGI-S - Week 12 (mITT w/LOCF Population)
Week 12 CGI-S Scale
|
3.000 units on a scale
Standard Deviation 1.333
|
3.007 units on a scale
Standard Deviation 1.250
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of the Clinicians Global Impression of Change (CGI-C) Score at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-c assesses the overall change in the severity of illness (depression). The clinician rates the subject's change based on a bipolar scale from 1(minimum; "Very much improved") to 7(maximum; "Very much worse"). A lower score indicates lower levels of depression as compared to baseline, a higher score indicates higher levels of depression as compared to baseline. A score of 4 ("Unchanged") indicates no change in illness compared to baseline. The scale is not calculated as a statistical change score; the clinician rates their impression of change overall.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=150 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CGI-C - Week 12 (mITT w/LOCF Population)
|
2.387 units on a scale
Standard Deviation 1.208
|
2.386 units on a scale
Standard Deviation 1.138
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of the CGI-C percent responders at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. CGI-C responders were defined as a score of 1 or 2 at the end of the study. A non-responder was defined as a score of ≥3 at end of study. Maximum score is 100%.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=150 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CGI-C Percent Responders (mITT w/LOCF Population)
Percent Non-Responder
|
40.7 Percent Responder
|
41.4 Percent Responder
|
|
CGI-C Percent Responders (mITT w/LOCF Population)
Percent Responder
|
59.3 Percent Responder
|
58.6 Percent Responder
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksA summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time. CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=149 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
Baseline- Observed
|
49.4 units on a scale
Standard Deviation 11.27
|
48.8 units on a scale
Standard Deviation 10.1
|
|
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
Week 12- Observed
|
30.7 units on a scale
Standard Deviation 13.55
|
30.5 units on a scale
Standard Deviation 13.36
|
|
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
Week 12 - Change From Baseline
|
-18.7 units on a scale
Standard Deviation 14.09
|
-18.3 units on a scale
Standard Deviation 14.27
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time. Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column. CDRS-R (Best Description)total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior.
Outcome measures
| Measure |
Placebo
n=154 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=150 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
Baseline - Observed
|
60.7 units on a scale
Standard Deviation 12.26
|
59.5 units on a scale
Standard Deviation 11.05
|
|
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
Week 12 - Observed
|
38 units on a scale
Standard Deviation 16.62
|
37 units on a scale
Standard Deviation 15.73
|
|
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
Week 12 - Change From Baseline
|
-22.7 units on a scale
Standard Deviation 16.54
|
-22.5 units on a scale
Standard Deviation 16.97
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of the secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Child), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC). CDRS-R (Child) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior.
Outcome measures
| Measure |
Placebo
n=151 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=146 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
Baseline - Observed
|
58.1 units on a scale
Standard Deviation 12.64
|
56.6 units on a scale
Standard Deviation 12.39
|
|
CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
Week 12 - Observed
|
30.8 units on a scale
Standard Deviation 12.41
|
31.1 units on a scale
Standard Deviation 12.38
|
|
CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
Week 12 - Change From Baseline
|
-25.5 units on a scale
Standard Deviation 15.07
|
-25.3 units on a scale
Standard Deviation 15.16
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC). CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation.
Outcome measures
| Measure |
Placebo
n=151 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=146 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
Baseline - Observed
|
49.6 units on a scale
Standard Deviation 11.43
|
48.9 units on a scale
Standard Deviation 10.21
|
|
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
Week 12 - Observed
|
25.5 units on a scale
Standard Deviation 10.70
|
25.8 units on a scale
Standard Deviation 9.59
|
|
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
Week 12 - Change From Baseline
|
-22.6 units on a scale
Standard Deviation 12.97
|
-22.2 units on a scale
Standard Deviation 12.66
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with observed cases (w/OC). Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom area. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column. CDRS-R (Best Description) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior.
Outcome measures
| Measure |
Placebo
n=151 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=146 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
Baseline - Observed
|
60.7 units on a scale
Standard Deviation 12.34
|
59.4 units on a scale
Standard Deviation 11.10
|
|
CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
Week 12 - Observed
|
32.1 units on a scale
Standard Deviation 13.18
|
32.4 units on a scale
Standard Deviation 12.75
|
|
CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
Week 12 - Change From Baseline
|
-27 units on a scale
Standard Deviation 14.93
|
-26.6 units on a scale
Standard Deviation 15.18
|
SECONDARY outcome
Timeframe: 12 WeeksNumber of physical examination findings that were normal at screening, but abnormal at end of study are presented. Four subjects receiving placebo and four subjects receiving EMSAM had abnormal findings on physical examination at the end of study that were normal at screening.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Physical Examination (Screening vs. EOS)
|
4 Number of Abnormal Exams
|
4 Number of Abnormal Exams
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary safety outcome measure, Urinalysis (Change from Baseline), by treatment assigned, is shown for the safety population. Mean changes from baseline are provided for PH and specific gravity.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Urinalysis (Change From Baseline)
PH
|
-0.02 units on a scale
Standard Deviation 0.906
|
-0.11 units on a scale
Standard Deviation 1.052
|
|
Urinalysis (Change From Baseline)
Specific Gravity
|
0.00 units on a scale
Standard Deviation 0.008
|
0.00 units on a scale
Standard Deviation 0.008
|
SECONDARY outcome
Timeframe: 12 WeeksSummary mean change in heart rate measured in beats per minute (beats/min or BPM) (supine, standing, and orthostatic change)results for all subjects are presented.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=131 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Vital Signs-Heart Rate (Change From Baseline)
Supine Heart Rate
|
.20 BPM
Standard Deviation 11.90
|
-.10 BPM
Standard Deviation 9.91
|
|
Vital Signs-Heart Rate (Change From Baseline)
Standing Heart Rate
|
-0.6 BPM
Standard Deviation 14.26
|
2.6 BPM
Standard Deviation 15.12
|
|
Vital Signs-Heart Rate (Change From Baseline)
Orthostatic Change in Heart Rate
|
-.80 BPM
Standard Deviation 11.70
|
2.80 BPM
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 12 WeeksSummary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=131 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Vital Signs-Blood Pressure (Change From Baseline)
Supine Systolic Blood Pressure
|
0.9 mmHg
Standard Deviation 8.94
|
-0.3 mmHg
Standard Deviation 11.8
|
|
Vital Signs-Blood Pressure (Change From Baseline)
Supine Diastolic Blood Pressure
|
1.1 mmHg
Standard Deviation 8.21
|
1.4 mmHg
Standard Deviation 8.52
|
|
Vital Signs-Blood Pressure (Change From Baseline)
Standing Systolic Blood Pressure
|
-1.2 mmHg
Standard Deviation 10.29
|
-2.5 mmHg
Standard Deviation 11.63
|
|
Vital Signs-Blood Pressure (Change From Baseline)
Standing Diastolic Blood Pressure
|
0.8 mmHg
Standard Deviation 8.5
|
-0.1 mmHg
Standard Deviation 9.11
|
|
Vital Signs-Blood Pressure (Change From Baseline)
Orthostatic Change in Systolic Blood Pressure
|
-2.1 mmHg
Standard Deviation 9.32
|
-2.3 mmHg
Standard Deviation 11.30
|
|
Vital Signs-Blood Pressure (Change From Baseline)
Orthostatic Change in Diastolic Blood Pressure
|
-0.4 mmHg
Standard Deviation 7.84
|
-1.5 mmHg
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline) measured in milliseconds (msec), by treatment assigned, is shown for the safety population. Mean change from Baseline in PR interval, QRS duration, QT interval, and QTc (Bazett and Fridericia corrections) interval are presented.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
12 Lead ECG (Change From Baseline)
PR Interval
|
0.70 msec
Standard Deviation 10.47
|
-0.90 msec
Standard Deviation 11.04
|
|
12 Lead ECG (Change From Baseline)
QRS Duration
|
-0.0 msec
Standard Deviation 5.84
|
1.1 msec
Standard Deviation 8.21
|
|
12 Lead ECG (Change From Baseline)
QT Interval
|
1.30 msec
Standard Deviation 24.86
|
3.80 msec
Standard Deviation 21.51
|
|
12 Lead ECG (Change From Baseline)
QTc (Bazett Correction) Interval
|
-4.10 msec
Standard Deviation 19.20
|
-2.90 msec
Standard Deviation 20.23
|
|
12 Lead ECG (Change From Baseline)
QTc (Fridericia Correction) Interval
|
-2.30 msec
Standard Deviation 16.06
|
-0.60 msec
Standard Deviation 15.27
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline)Ventricular Heart Rate measured in beats per minute(beats/min or BPM), by treatment assigned, is shown for the safety population. Mean change from baseline is presented.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
12 Lead ECG (Change From Baseline)Ventricular Heart Rate
|
-1.70 BPM
Standard Deviation 10.40
|
-2.40 BPM
Standard Deviation 10.43
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary safety outcome measure, Hematology (Change from Baseline), by treatment assigned, is shown for the safety population. Mean change from Baseline in ABS BASOPHILS (X10\^9/L), ABS EOSINOPHILS (X10\^9/L), ABS LYMPHOCYTES (X10\^9/L), ABS MONOCYTES (X10\^9/L), and ABS NEUTROPHILS (X10\^9/L) are presented.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Hematology - White Blood Cell (WBC) (Change From Baseline)
ABS BASOPHILS (X10^9/L)
|
-0.00 (X10^9/L)
Standard Deviation 0.040
|
0.00 (X10^9/L)
Standard Deviation 0.035
|
|
Hematology - White Blood Cell (WBC) (Change From Baseline)
ABS EOSINOPHILS (X10^9/L)
|
-0.01 (X10^9/L)
Standard Deviation 0.1
|
0.01 (X10^9/L)
Standard Deviation 0.115
|
|
Hematology - White Blood Cell (WBC) (Change From Baseline)
ABS LYMPHOCYTES (X10^9/L)
|
-0.09 (X10^9/L)
Standard Deviation 0.535
|
-0.03 (X10^9/L)
Standard Deviation 0.538
|
|
Hematology - White Blood Cell (WBC) (Change From Baseline)
ABS MONOCYTES (X10^9/L)
|
0.01 (X10^9/L)
Standard Deviation 0.134
|
-0.00 (X10^9/L)
Standard Deviation 0.148
|
|
Hematology - White Blood Cell (WBC) (Change From Baseline)
ABS NEUTROPHILS (X10^9/L)
|
0.01 (X10^9/L)
Standard Deviation 1.542
|
-0.10 (X10^9/L)
Standard Deviation 1.346
|
|
Hematology - White Blood Cell (WBC) (Change From Baseline)
PLATELETS (X10^9/L)
|
-0.01 (X10^9/L)
Standard Deviation 44.126
|
1.82 (X10^9/L)
Standard Deviation 54.452
|
|
Hematology - White Blood Cell (WBC) (Change From Baseline)
WBC (X10^9/L)
|
-0.09 (X10^9/L)
Standard Deviation 1.813
|
-0.12 (X10^9/L)
Standard Deviation 1.614
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Hematology - Hematocrit (Change From Baseline)
|
-0.58 percent
Standard Deviation 2.294
|
-1.13 percent
Standard Deviation 3.093
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Hematology - Hemoglobin (Change From Baseline)
|
-0.18 g/dL
Standard Deviation 0.694
|
-0.36 g/dL
Standard Deviation 0.854
|
SECONDARY outcome
Timeframe: 12 WeeksA summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 Participants
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Hematology - Red Blood Cell (Change From Baseline)
|
-0.04 x10^12/L
Standard Deviation 0.234
|
-0.12 x10^12/L
Standard Deviation 0.313
|
Adverse Events
Placebo
EMSAM
Serious adverse events
| Measure |
Placebo
n=156 participants at risk
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 participants at risk
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/156 • 12 weeks
|
1.3%
2/152 • Number of events 2 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/156 • 12 weeks
|
0.66%
1/152 • Number of events 1 • 12 weeks
|
|
General disorders
Loss of Consciousness
|
0.64%
1/156 • Number of events 1 • 12 weeks
|
0.00%
0/152 • 12 weeks
|
|
Psychiatric disorders
Mood Swings
|
0.64%
1/156 • Number of events 1 • 12 weeks
|
0.00%
0/152 • 12 weeks
|
|
General disorders
Orthstatic Hypotension
|
0.00%
0/156 • 12 weeks
|
0.66%
1/152 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/156 • 12 weeks
|
0.66%
1/152 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Screaming
|
0.00%
0/156 • 12 weeks
|
0.66%
1/152 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
0.64%
1/156 • Number of events 1 • 12 weeks
|
1.3%
2/152 • Number of events 2 • 12 weeks
|
|
General disorders
Syncope
|
0.00%
0/156 • 12 weeks
|
0.66%
1/152 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/156 • Number of events 1 • 12 weeks
|
0.66%
1/152 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=156 participants at risk
Placebo Selegiline Transdermal System 6, 9 or 12
Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
EMSAM
n=152 participants at risk
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
2.0%
3/152 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.5%
7/156 • Number of events 7 • 12 weeks
|
2.6%
4/152 • Number of events 4 • 12 weeks
|
|
Psychiatric disorders
Agitation
|
1.9%
3/156 • Number of events 3 • 12 weeks
|
2.6%
4/152 • Number of events 4 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
1.3%
2/156 • Number of events 2 • 12 weeks
|
2.6%
4/152 • Number of events 4 • 12 weeks
|
|
General disorders
Application Site Reaction
|
21.8%
34/156 • Number of events 34 • 12 weeks
|
24.3%
37/152 • Number of events 37 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
2.6%
4/152 • Number of events 4 • 12 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.3%
2/156 • Number of events 2 • 12 weeks
|
3.3%
5/152 • Number of events 5 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
7/156 • Number of events 7 • 12 weeks
|
3.3%
5/152 • Number of events 5 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
4.5%
7/156 • Number of events 7 • 12 weeks
|
5.3%
8/152 • Number of events 8 • 12 weeks
|
|
General disorders
Fatigue
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
2.6%
4/152 • Number of events 4 • 12 weeks
|
|
Nervous system disorders
Headache
|
16.7%
26/156 • Number of events 26 • 12 weeks
|
17.1%
26/152 • Number of events 26 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
5.9%
9/152 • Number of events 9 • 12 weeks
|
|
Psychiatric disorders
Irritability
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
1.3%
2/152 • Number of events 2 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
7/156 • Number of events 7 • 12 weeks
|
3.9%
6/152 • Number of events 6 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.7%
12/156 • Number of events 12 • 12 weeks
|
7.2%
11/152 • Number of events 11 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
1.9%
3/156 • Number of events 3 • 12 weeks
|
2.6%
4/152 • Number of events 4 • 12 weeks
|
|
Nervous system disorders
Somnolence
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
4.6%
7/152 • Number of events 7 • 12 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
2.6%
4/152 • Number of events 4 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
7.2%
11/152 • Number of events 11 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
4/156 • Number of events 4 • 12 weeks
|
4.6%
7/152 • Number of events 7 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator is free to publish for their own research or publication objectives, provided that such does not disclose Confidential Information. At least 45 days prior the Investigator shall submit for Sponsor review. Sponsor will advise of revisions necessary to preserve confidential and proprietary information. The first publication of the results shall be a joint Multi-Center publication of results with the investigators from all study sites contributing data.
- Publication restrictions are in place
Restriction type: OTHER