Effects of Antidepressants on Sexual Functioning - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00051259

Purpose

The purpose of this trial is to study the effects of two depression medications on sexual functioning.

Condition	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: Extended-Release Bupropion Hydrochloride	Phase III

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.

Secondary Outcome Measures:

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

Estimated Enrollment:	420
Study Start Date:	January 2003

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: NCT00051259

Show 23 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AK130926
Study First Received:	January 7, 2003
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00051259
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

depression
MDD
sexual dysfunction
orgasm disorder

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Bupropion
Mood Disorders

Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009