Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects Of Antidepressants On Sexual Functioning In Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00051272
First received: January 7, 2003
Last updated: March 28, 2011
Last verified: March 2011

January 7, 2003
March 28, 2011
January 2003
June 2004   (final data collection date for primary outcome measure)
Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
Not Provided
Complete list of historical versions of study NCT00051272 on ClinicalTrials.gov Archive Site
Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17.
Not Provided
Not Provided
Not Provided
 
Effects Of Antidepressants On Sexual Functioning In Adults
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

This study will evaluate the effects of two antidepression medications on sexual functioning.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder (MDD)
Drug: Extended-release Bupropion Hydrochloride
Other Name: Extended-release Bupropion Hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051272
AK130927
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
March 2011

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