Effects Of Antidepressants On Sexual Functioning In Adults

Phase 3

Completed

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT00051272
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will evaluate the effects of two antidepression 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: 2011-03
• Last Update Submitted: 2011-03-28
• Last Update Posted: 2011-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Yakima, Washington, United States