NCT00531947

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

A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible Dose Study of the Safety and Efficacy of EMSAM in Adolescents With Major Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Somerset Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Selegiline Transdermal System	EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study
DRUG	Placebo	Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2007-09-19
• Last updated: 2014-01-15
• Results posted: 2013-06-26

Locations

20 sites across 1 country: United States