Effects of Antidepressants on Sexual Functioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00051259
Recruitment Status : Completed
First Posted : January 8, 2003
Last Update Posted : October 4, 2010
Information provided by:

January 7, 2003
January 8, 2003
October 4, 2010
January 2003
June 2004   (Final data collection date for primary outcome measure)
Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.
Not Provided
Complete list of historical versions of study NCT00051259 on Archive Site
Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.
Not Provided
Not Provided
Not Provided
Effects of Antidepressants on Sexual Functioning
A Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Effects on Sexual Functioning of Extended-Release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period
The purpose of this trial is to study the effects of two depression medications on sexual functioning.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Major Depressive Disorder (MDD)
Drug: Extended-Release Bupropion Hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
June 2004
June 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
  • Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
  • Subject must have normal orgasmic function and be willing to discuss with investigator.

Exclusion Criteria:

  • Subjects that have arousal or orgasm dysfunction.
  • Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
  • Subject has other unstable medical disorders.
  • Subject has a positive urine test for illicit drug use at screening.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Study Director, GSK
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
October 2010

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