The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major Depressive Disorder (MDD).
• Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for Major Depressive Disorder (MDD) without psychotic features, single or recurrent
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
308
EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
Dr. Nelson Handal
Dothan, Alabama, United States
Dr. Mohammed Bari
National City, California, United States
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
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
CGI-S - Week 12 (mITT w/LOCF Population)
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
CGI-C - Week 12 (mITT w/LOCF Population)
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
CGI-C Percent Responders (mITT w/LOCF Population)
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Dr. Michael McManus
San Diego, California, United States
Dr. Elias Sarkis
Gainesville, Florida, United States
Dr. Scott Segal
North Miami, Florida, United States
Dr. Mary Stedman
Tampa, Florida, United States
Dr. Irving Kolin
Winter Park, Florida, United States
Dr. Rory Murphy
Overland Park, Kansas, United States
Dr. Andrew Sediloo
Owensboro, Kentucky, United States
Dr. Bruce Waslick
Springfield, Massachusetts, United States
...and 10 more locations
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
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)
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
CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)
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
CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)
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
CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)
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
CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)
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
Physical Examination (Screening vs. EOS)
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
Urinalysis (Change From Baseline)
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
Vital Signs-Heart Rate (Change From Baseline)
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
Vital Signs-Blood Pressure (Change From Baseline)
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
12 Lead ECG (Change From Baseline)
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
12 Lead ECG (Change From Baseline)Ventricular Heart Rate
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
Hematology - White Blood Cell (WBC) (Change From Baseline)
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
Hematology - Hematocrit (Change From Baseline)
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
Hematology - Hemoglobin (Change From Baseline)
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
Hematology - Red Blood Cell (Change From Baseline)
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