Effects of Antidepressants on Sexual Functioning

Phase 3

Completed

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT00051259
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this trial is to study the effects of two depression medications on sexual functioning.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-01-07
• Study First Submitted QC: 2003-01-07
• Study First Posted: 2003-01-08
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-01
• Last Update Posted: 2010-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.

Secondary Outcome Measures

Name	Time	Method
Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Madison, Wisconsin, United States