Effects of Antidepressants on Sexual Functioning

NCT ID: NCT00051259

Last Updated: 2010-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-06-30

Brief Summary

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

Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Extended-Release Bupropion Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Berkeley, California, United States

Site Status

GSK Investigational Site

Beverly Hills, California, United States

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La Mesa, California, United States

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Oceanside, California, United States

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Coral Springs, Florida, United States

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Jacksonville, Florida, United States

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Indianapolis, Indiana, United States

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Terre Haute, Indiana, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Minneapolis, Minnesota, United States

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New York, New York, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Bellaire, Texas, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Countries

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United States

Other Identifiers

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AK130926

Identifier Type: -

Identifier Source: org_study_id