Effects of Antidepressants on Sexual Functioning

October 1, 2010 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94709
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • La Mesa, California, United States, 91942
        • GSK Investigational Site
      • Oceanside, California, United States, 92056
        • GSK Investigational Site
    • Florida
      • Coral Springs, Florida, United States, 33065
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
      • Terre Haute, Indiana, United States, 47802
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • GSK Investigational Site
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10021
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43623
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865-4208
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53719
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.

Secondary Outcome Measures

Outcome Measure
Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

January 7, 2003

First Submitted That Met QC Criteria

January 7, 2003

First Posted (Estimate)

January 8, 2003

Study Record Updates

Last Update Posted (Estimate)

October 4, 2010

Last Update Submitted That Met QC Criteria

October 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK130926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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