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

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT00531947

Run by

Somerset Pharmaceuticals

People needed

308

Starts

2007-07-01

Expected to finish

2010-10-01

Last updated by the study team

2014-01-15

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dr. Nelson Handal — Dothan, Alabama, United States
• Dr. Mohammed Bari — National City, California, United States
• Dr. Michael McManus — San Diego, California, United States
• Dr. Elias Sarkis — Gainesville, Florida, United States
• Dr. Scott Segal — North Miami, Florida, United States
• Dr. Mary Stedman — Tampa, Florida, United States
• Dr. Irving Kolin — Winter Park, Florida, United States
• Dr. Rory Murphy — Overland Park, Kansas, United States
• Dr. Andrew Sediloo — Owensboro, Kentucky, United States
• Dr. Bruce Waslick — Springfield, Massachusetts, United States
• Dr. Christopher Kratochvil — Omaha, Nebraska, United States
• Dr. Ann Childress — Las Vegas, Nevada, United States
• Dr. Melissa DelBello — Cincinnati, Ohio, United States
• Dr. Leland Dennis — Oklahoma City, Oklahoma, United States
• Dr. David Brown — Austin, Texas, United States
• Dr. Alain Katic — Bellaire, Texas, United States
• Dr. Graham Emslie — Dallas, Texas, United States
• Dr. Mary Shemo — Charlottesville, Virginia, United States
• Dr. John Gilliam — Richmond, Virginia, United States
• Dr. Arifulla Khan — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.