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Effects of Antidepressants on Sexual Functioning

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ClinicalTrials.gov Identifier: NCT00051259
Recruitment Status : Completed
First Posted : January 8, 2003
Last Update Posted : October 4, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

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 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

Resource links provided by the National Library of Medicine





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.


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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.

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


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00051259     History of Changes
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:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
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