Sexual Functioning Study With Antidepressants - Tabular View

Tracking Information

First Received Date ^ICMJE

April 18, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00316160 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy, Safety, Tolerability, Health Outcome

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Sexual Functioning Study With Antidepressants

Official Title ^ICMJE

See Detailed Description

Brief Summary

Effects of two depression medication on sexual functioning

Detailed Description

A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) in Subjects with Major Depressive Disorder

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Major Depressive Disorder (MDD)

Intervention ^ICMJE

Drug: Bupropion Hydrochloride Extended-release
Drug: Extended-release Venlafaxine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

344

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Primary diagnosis of Major Depressive Disorder (MDD)
must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
HAM-D17 total score of >17 at screening and baseline.
Severity of illness score of >4 at screening and baseline.
Willing to discuss sexual functioning with investigator or designee.
Sexual activity that leads to orgasm at least every 2 weeks.

Exclusion Criteria:

Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).
Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.
Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
Myocardial infarction with 1 year of screening.
Taken ibupropion hydrochloride or venlafaxine in the last 6 months.
Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
Psychotherapy within 3 months.
Pregnant.
Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
ECG or clinical evidence of atrial or ventricular hypertrophy.

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 ID ^ICMJE

NCT00316160

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

100368

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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