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

Somerset Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Selegiline Transdermal System

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00531947

S9303-P0605

Details and patient eligibility

About

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).

Full 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

Enrollment

308 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male / Female outpatients 12 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised [CDRS-R] with a total score of at least 45 at screening.)
Female patients must test negative on a pregnancy at visit 1.
Weight and height must be greater than the 10th percentile according to age and height,
Assent and consent must be given.

Exclusion criteria

Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ECG result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
Have a risk of suicide
Female patients who are either pregnant, nursing or have recently given birth.
Use of any protocol prohibited medications or substances.