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Effects of Antidepressants on Sexual Functioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00051259
Recruitment Status : Completed
First Posted : January 8, 2003
Last Update Posted : October 4, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this trial is to study the effects of two depression medications on sexual functioning.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: Extended-Release Bupropion Hydrochloride Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051259


Locations
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United States, California
GSK Investigational Site
Berkeley, California, United States, 94709
GSK Investigational Site
Beverly Hills, California, United States, 90210
GSK Investigational Site
La Mesa, California, United States, 91942
GSK Investigational Site
Oceanside, California, United States, 92056
United States, Florida
GSK Investigational Site
Coral Springs, Florida, United States, 33065
GSK Investigational Site
Jacksonville, Florida, United States, 32216
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21208
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44109
GSK Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Rhode Island
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29407
United States, Texas
GSK Investigational Site
Bellaire, Texas, United States, 77401
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
GSK Investigational Site
Richmond, Virginia, United States, 23294
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information
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Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00051259    
Other Study ID Numbers: AK130926
First Posted: January 8, 2003    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010
Keywords provided by GlaxoSmithKline:
depression
MDD
sexual dysfunction
orgasm disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors