Effects Of Antidepressants On Sexual Functioning In Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00051272
First received: January 7, 2003
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder (MDD)
Drug: Extended-release Bupropion Hydrochloride
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.

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

Enrollment: 425
Study Start Date: January 2003
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Extended-release Bupropion Hydrochloride
    Other Name: Extended-release Bupropion Hydrochloride
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051272

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00051272     History of Changes
Other Study ID Numbers: AK130927
Study First Received: January 7, 2003
Last Updated: March 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
depression, sexual dysfunction, orgasm disorder, MDD

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Bupropion
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014