CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 308 enrolled
Drug / intervention
Selegiline Transdermal System +1 moredrug
Likely dose
Selegiline Transdermal System 6mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00531947
NCT00531947Phase 4Completed
CompareCT.gov

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

Somerset Pharmaceuticals·interventional·Posted Sep 19, 2007·Updated Jan 15, 2014

In Brief

A Phase 4 clinical trial evaluating Selegiline Transdermal System and Placebo for Major Depressive Disorder. Completed, enrolled 308 participants across 20 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2007
Enrollment StartJul 1, 2007
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.8 years ago

Interventions

Selegiline Transdermal Systemdrug

EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study

Placebodrug

Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study