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NCT00051272 Clinical Trial

Effects Of Antidepressants On Sexual Functioning In Adults

Major Depressive Disorder (MDD) Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00051272
Other study ID # AK130927
Secondary ID
Status Completed
Phase Phase 3
First received January 7, 2003
Last updated March 28, 2011
Start date January 2003
Est. completion date June 2004

Study information
Verified date March 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will evaluate the effects of two antidepression medications on sexual functioning.

Recruitment information / eligibility
Status Completed
Enrollment 425
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Extended-release Bupropion Hydrochloride

Locations
Country Name City State
United States GSK Investigational Site Baton Rouge Louisiana
United States GSK Investigational Site Bellaire Texas
United States GSK Investigational Site Berkeley California
United States GSK Investigational Site Boise Idaho
United States GSK Investigational Site Braintree Massachusetts
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site Middletown Connecticut
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site New York New York
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Piscataway New Jersey
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Scottsdale Arizona
United States GSK Investigational Site Smyrna Georgia
United States GSK Investigational Site Washington District of Columbia
United States GSK Investigational Site Wilmington Delaware
United States GSK Investigational Site Yakima Washington

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
Secondary Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17.
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