Effects Of Antidepressants On Sexual Functioning In Adults

NCT ID: NCT00051272

Last Updated: 2011-03-29

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

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-06-30

Brief Summary

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This study will evaluate the effects of two antidepression 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

Participants Investigators

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

Phoenix, Arizona, United States

Site Status

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Scottsdale, Arizona, United States

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Berkeley, California, United States

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Middletown, Connecticut, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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Marietta, Georgia, United States

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Smyrna, Georgia, United States

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Boise, Idaho, United States

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Baton Rouge, Louisiana, United States

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Braintree, Massachusetts, United States

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Piscataway, New Jersey, United States

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New York, New York, United States

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Raleigh, North Carolina, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Nashville, Tennessee, United States

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Bellaire, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Yakima, Washington, United States

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Countries

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United States

Other Identifiers

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AK130927

Identifier Type: -

Identifier Source: org_study_id

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