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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 24 Study Locations
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 May 16, 2013