Conditions: Major Depressive Disorder
Keywords: Mental Health Adolescents Major Depressive Disorder Depression Adolescent Depression Pediatric Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 308
Healthy volunteers: no

Brief summary:
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).

Detailed description:
• 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

Arms:
arm 1: Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg arm 2: Placebo Selegiline Transdermal System 6, 9 or 12

Interventions: intervention 1: Selegiline Transdermal System intervention 2: Placebo
Intervention descriptions: intervention 1: EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study intervention 2: Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study

Protocol document: