Effects Of Antidepressants On Sexual Functioning In Adults

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Drug: Extended-release Bupropion Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • GSK Investigational Site
    • Scottsdale, Arizona, United States, 85251
      • GSK Investigational Site
  • California
    • Berkeley, California, United States, 94709
      • GSK Investigational Site
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • GSK Investigational Site
  • Delaware
    • Wilmington, Delaware, United States, 19808
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GSK Investigational Site
  • Florida
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
  • Georgia
    • Marietta, Georgia, United States, 30060
      • GSK Investigational Site
    • Smyrna, Georgia, United States, 30080
      • GSK Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83702
      • GSK Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • GSK Investigational Site
  • Massachusetts
    • Braintree, Massachusetts, United States, 02184
      • GSK Investigational Site
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10128
      • GSK Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • GSK Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • GSK Investigational Site
  • Texas
    • Bellaire, Texas, United States, 77401
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229-3815
      • GSK Investigational Site
    • San Antonio, Texas, United States
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • GSK Investigational Site
  • Washington
    • Yakima, Washington, United States, 98902
      • GSK Investigational Site

Participation Criteria

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

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
Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

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): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: depression, sexual dysfunction, orgasm disorder, MDD
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: AK130927