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Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00531947
Recruitment Status : Completed
First Posted : September 19, 2007
Results First Posted : June 26, 2013
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
Somerset Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Selegiline Transdermal System
Drug: Placebo
Enrollment 308
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 156 [1] 152 [2]
Completed 114 101
Not Completed 42 51
Reason Not Completed
Adverse Event             5             10
Lost to Follow-up             12             9
Withdrawal by Subject             14             19
Protocol Violation             2             1
Non-Compliance             4             7
Other (e.g., Lack of Efficacy)             5             5
[1]
all randomized subjects who received at least one dose of placebo study medication
[2]
all randomized subjects who received at least one dose of EMSAM study medication
Arm/Group Title Placebo EMSAM Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 156 152 308
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 152 participants 308 participants
<=18 years
156
 100.0%
152
 100.0%
308
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 152 participants 308 participants
14.7  (1.6) 14.8  (1.62) 14.8  (1.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 152 participants 308 participants
Female
104
  66.7%
93
  61.2%
197
  64.0%
Male
52
  33.3%
59
  38.8%
111
  36.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 152 participants 308 participants
Caucasian 77 69 146
Black 34 46 80
Hispanic 37 32 69
Asian 2 1 3
Native American 1 1 2
Other 5 3 8
1.Primary Outcome
Title CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
Hide Description

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.

Time Frame baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 154 150
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline - Observed 57.9  (12.57) 56.7  (12.34)
Week 12 - Observed 36.4  (15.91) 35.4  (15.30)
Week 12 - Change From Baseline -21.5  (16.47) -21.4  (16.61)
2.Secondary Outcome
Title CGI-S - Week 12 (mITT w/LOCF Population)
Hide Description 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.
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 154 150
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline CGI-S Scale 4.494  (0.659) 4.527  (0.662)
Week 12 CGI-S Scale 3.000  (1.333) 3.007  (1.250)
3.Secondary Outcome
Title CGI-C - Week 12 (mITT w/LOCF Population)
Hide Description A 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 154 150
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.387  (1.208) 2.386  (1.138)
4.Secondary Outcome
Title CGI-C Percent Responders (mITT w/LOCF Population)
Hide Description A 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%.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 154 150
Measure Type: Number
Unit of Measure: Percent Responder
Percent Non-Responder 40.7 41.4
Percent Responder 59.3 58.6
5.Secondary Outcome
Title CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
Hide Description

A 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.

Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 154 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline- Observed 49.4  (11.27) 48.8  (10.1)
Week 12- Observed 30.7  (13.55) 30.5  (13.36)
Week 12 - Change From Baseline -18.7  (14.09) -18.3  (14.27)
6.Secondary Outcome
Title CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
Hide Description

A 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.

Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 154 150
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline - Observed 60.7  (12.26) 59.5  (11.05)
Week 12 - Observed 38  (16.62) 37  (15.73)
Week 12 - Change From Baseline -22.7  (16.54) -22.5  (16.97)
7.Secondary Outcome
Title CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
Hide Description

A 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.

Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline - Observed 58.1  (12.64) 56.6  (12.39)
Week 12 - Observed 30.8  (12.41) 31.1  (12.38)
Week 12 - Change From Baseline -25.5  (15.07) -25.3  (15.16)
8.Secondary Outcome
Title CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
Hide Description

A 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.

Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline - Observed 49.6  (11.43) 48.9  (10.21)
Week 12 - Observed 25.5  (10.70) 25.8  (9.59)
Week 12 - Change From Baseline -22.6  (12.97) -22.2  (12.66)
9.Secondary Outcome
Title CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
Hide Description

A 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.

Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline - Observed 60.7  (12.34) 59.4  (11.10)
Week 12 - Observed 32.1  (13.18) 32.4  (12.75)
Week 12 - Change From Baseline -27  (14.93) -26.6  (15.18)
10.Secondary Outcome
Title Physical Examination (Screening vs. EOS)
Hide Description Number 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Measure Type: Number
Unit of Measure: Number of Abnormal Exams
4 4
11.Secondary Outcome
Title Urinalysis (Change From Baseline)
Hide Description A 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
PH -0.02  (0.906) -0.11  (1.052)
Specific Gravity 0.00  (0.008) 0.00  (0.008)
12.Secondary Outcome
Title Vital Signs-Heart Rate (Change From Baseline)
Hide Description Summary 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 139 131
Mean (Standard Deviation)
Unit of Measure: BPM
Supine Heart Rate .20  (11.90) -.10  (9.91)
Standing Heart Rate -0.6  (14.26) 2.6  (15.12)
Orthostatic Change in Heart Rate -.80  (11.70) 2.80  (13.8)
13.Secondary Outcome
Title Vital Signs-Blood Pressure (Change From Baseline)
Hide Description Summary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 139 131
Mean (Standard Deviation)
Unit of Measure: mmHg
Supine Systolic Blood Pressure 0.9  (8.94) -0.3  (11.8)
Supine Diastolic Blood Pressure 1.1  (8.21) 1.4  (8.52)
Standing Systolic Blood Pressure -1.2  (10.29) -2.5  (11.63)
Standing Diastolic Blood Pressure 0.8  (8.5) -0.1  (9.11)
Orthostatic Change in Systolic Blood Pressure -2.1  (9.32) -2.3  (11.30)
Orthostatic Change in Diastolic Blood Pressure -0.4  (7.84) -1.5  (7.85)
14.Secondary Outcome
Title 12 Lead ECG (Change From Baseline)
Hide Description A 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: msec
PR Interval 0.70  (10.47) -0.90  (11.04)
QRS Duration -0.0  (5.84) 1.1  (8.21)
QT Interval 1.30  (24.86) 3.80  (21.51)
QTc (Bazett Correction) Interval -4.10  (19.20) -2.90  (20.23)
QTc (Fridericia Correction) Interval -2.30  (16.06) -0.60  (15.27)
15.Secondary Outcome
Title 12 Lead ECG (Change From Baseline)Ventricular Heart Rate
Hide Description A 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: BPM
-1.70  (10.40) -2.40  (10.43)
16.Secondary Outcome
Title Hematology - White Blood Cell (WBC) (Change From Baseline)
Hide Description A 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.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: (X10^9/L)
ABS BASOPHILS (X10^9/L) -0.00  (0.040) 0.00  (0.035)
ABS EOSINOPHILS (X10^9/L) -0.01  (0.1) 0.01  (0.115)
ABS LYMPHOCYTES (X10^9/L) -0.09  (0.535) -0.03  (0.538)
ABS MONOCYTES (X10^9/L) 0.01  (0.134) -0.00  (0.148)
ABS NEUTROPHILS (X10^9/L) 0.01  (1.542) -0.10  (1.346)
PLATELETS (X10^9/L) -0.01  (44.126) 1.82  (54.452)
WBC (X10^9/L) -0.09  (1.813) -0.12  (1.614)
17.Secondary Outcome
Title Hematology - Hematocrit (Change From Baseline)
Hide Description A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: percent
-0.58  (2.294) -1.13  (3.093)
18.Secondary Outcome
Title Hematology - Hemoglobin (Change From Baseline)
Hide Description A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.18  (0.694) -0.36  (0.854)
19.Secondary Outcome
Title Hematology - Red Blood Cell (Change From Baseline)
Hide Description A summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: x10^12/L
-0.04  (0.234) -0.12  (0.313)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo EMSAM
Hide Arm/Group Description

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

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

All-Cause Mortality
Placebo EMSAM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo EMSAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/156 (1.92%)      7/152 (4.61%)    
Gastrointestinal disorders     
Vomiting  1  1/156 (0.64%)  1 1/152 (0.66%)  1
General disorders     
Loss of Consciousness  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Orthstatic Hypotension  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Syncope  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Psychiatric disorders     
Agitation  1  0/156 (0.00%)  0 2/152 (1.32%)  2
Anxiety  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Mood Swings  1  1/156 (0.64%)  1 0/152 (0.00%)  0
Psychotic Disorder  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Screaming  1  0/156 (0.00%)  0 1/152 (0.66%)  1
Suicidal Ideation  1  1/156 (0.64%)  1 2/152 (1.32%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo EMSAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/156 (57.69%)      95/152 (62.50%)    
Gastrointestinal disorders     
Abdominal Pain  1  4/156 (2.56%)  4 3/152 (1.97%)  3
Abdominal Pain Upper  1  7/156 (4.49%)  7 4/152 (2.63%)  4
Diarrhea  1  7/156 (4.49%)  7 5/152 (3.29%)  5
Nausea  1  12/156 (7.69%)  12 11/152 (7.24%)  11
Vomiting  1  4/156 (2.56%)  4 7/152 (4.61%)  7
General disorders     
Application Site Reaction  1  34/156 (21.79%)  34 37/152 (24.34%)  37
Fatigue  1  4/156 (2.56%)  4 4/152 (2.63%)  4
Infections and infestations     
Nasopharyngitis  1  7/156 (4.49%)  7 6/152 (3.95%)  6
Metabolism and nutrition disorders     
Decreased Appetite  1  2/156 (1.28%)  2 5/152 (3.29%)  5
Musculoskeletal and connective tissue disorders     
Back Pain  1  4/156 (2.56%)  4 4/152 (2.63%)  4
Nervous system disorders     
Dizziness  1  7/156 (4.49%)  7 8/152 (5.26%)  8
Headache  1  26/156 (16.67%)  26 26/152 (17.11%)  26
Somnolence  1  4/156 (2.56%)  4 7/152 (4.61%)  7
Psychiatric disorders     
Agitation  1  3/156 (1.92%)  3 4/152 (2.63%)  4
Anxiety  1  2/156 (1.28%)  2 4/152 (2.63%)  4
Insomnia  1  4/156 (2.56%)  4 9/152 (5.92%)  9
Irritability  1  4/156 (2.56%)  4 2/152 (1.32%)  2
Suicidal Ideation  1  4/156 (2.56%)  4 4/152 (2.63%)  4
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal Pain  1  3/156 (1.92%)  3 4/152 (2.63%)  4
Upper Respiratory Tract Infection  1  4/156 (2.56%)  4 11/152 (7.24%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Kim Portland, Ph.D.
Organization: Mylan Specialty L.P.
Phone: 908.542.2636
Responsible Party: Somerset Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00531947     History of Changes
Other Study ID Numbers: S9303-P0605
First Submitted: September 18, 2007
First Posted: September 19, 2007
Results First Submitted: December 27, 2012
Results First Posted: June 26, 2013
Last Update Posted: January 15, 2014