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

Tracking Information

First Received Date ^ICMJE

January 7, 2003

Last Updated Date

March 28, 2011

Start Date ^ICMJE

January 2003

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00051272 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects Of Antidepressants On Sexual Functioning In Adults

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Major Depressive Disorder (MDD)

Intervention ^ICMJE

Drug: Extended-release Bupropion Hydrochloride

Other Name: Extended-release Bupropion Hydrochloride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

425

Completion Date

June 2004

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00051272

Other Study ID Numbers ^ICMJE

AK130927

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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