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Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
This study is currently recruiting participants.
Study NCT00531947   Information provided by Somerset Pharmaceuticals
First Received: September 18, 2007   Last Updated: April 21, 2008   History of Changes

September 18, 2007
April 21, 2008
July 2007
 
Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features, single or recurrent [ Time Frame: 24 Months ]
Same as current
Complete list of historical versions of study NCT00531947 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

  • Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features, single or recurrent
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
  • Mental Health
  • Major Depressive Disorder
  • Drug: Selegiline Trandermal System
  • Drug: Placebo
  • Other: Approved Medication for Major Depresive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
  • Placebo Comparator: Placebo Selegiline Transdermal System 6, 9 or 12
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
300
 
 

Inclusion Criteria:

  • Male / Female outpatients 12 to 17 years of age diagnosed with MDD. (Must have a 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.
Both
12 Years to 17 Years
No
Contact: Thomas Hochadel, Pharm.D. 727-897-9000 thochadel@cogres.com
Contact: Melissa Goodhead 800-892-8889 mlg@somersetpharm.com
United States
 
NCT00531947
Melissa Goodhead, B.Sc., RAC, Somerset Pharmaceuticals, Inc.
S9303-P0605
Somerset Pharmaceuticals
 
Study Director: Thomas Hochadel, Pharm.D. Cognitive Research Corporation
Study Chair: Melissa L Goodhead Somerset Pharmaceuticals
Somerset Pharmaceuticals
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP