Effects Of Antidepressants On Sexual Functioning In Adults

This study has been completed.

First Received: January 7, 2003 Last Updated: March 6, 2006 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00051272

Purpose

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

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Extended-release Bupropion Hydrochloride	Phase III

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, 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:

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.

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: NCT00051272

Show 24 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Chair:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	AK130927
Study First Received:	January 7, 2003
Last Updated:	March 6, 2006
ClinicalTrials.gov Identifier:	NCT00051272 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

depression, sexual dysfunction, orgasm disorder, MDD

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Citalopram
Behavioral Symptoms

Dopamine
Mental Disorders
Bupropion
Mood Disorders
Dopamine Agents
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Pharmacologic Actions

Behavioral Symptoms
Mental Disorders
Therapeutic Uses
Bupropion
Mood Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009