Effects of Antidepressants on Sexual Functioning

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: NCT00051259
• Other study ID #: AK130926
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2003
• Last updated: October 1, 2010
• Start date: January 2003
• Est. completion date: June 2004

Study information

• Verified date: October 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Extended-Release Bupropion Hydrochloride

Locations

Country	Name	City	State
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bellaire	Texas
United States	GSK Investigational Site	Berkeley	California
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Coral Springs	Florida
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	La Mesa	California
United States	GSK Investigational Site	Lincoln	Rhode Island
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Oceanside	California
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Terre Haute	Indiana
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

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