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

NCT00531947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2014-01-15

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Somerset Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Thomas Hochadel, Pharm.D. · Cognitive Research Corporation

  • Melissa L Goodhead · Somerset Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531947 on ClinicalTrials.gov