Sexual Functioning Study With Antidepressants

May 24, 2017 updated by: GlaxoSmithKline

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

Effects of two depression medication on sexual functioning

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

347

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85023
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • GSK Investigational Site
    • California
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • Burbank, California, United States, 91506
        • GSK Investigational Site
      • La Mesa, California, United States, 91942
        • GSK Investigational Site
      • San Francisco, California, United States, 94109
        • GSK Investigational Site
      • Temecula, California, United States, 92591
        • GSK Investigational Site
      • Upland, California, United States, 91786
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80212
        • GSK Investigational Site
    • Florida
      • Coral Springs, Florida, United States, 33065
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
      • Smyrna, Georgia, United States, 30080
        • GSK Investigational Site
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • GSK Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Massachusetts
      • Braintree, Massachusetts, United States, 02184
        • GSK Investigational Site
      • Greenfield, Massachusetts, United States, 01301
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • GSK Investigational Site
      • New York, New York, United States, 10128
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43623
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73117
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Portland, Oregon, United States, 97209
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865-4208
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Bellaire, Texas, United States, 77401
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76107
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site
    • Washington
      • Yakima, Washington, United States, 98902
        • GSK Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562-2215
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
Efficacy, Safety, Tolerability, Health Outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 20, 2006

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder, Major

Clinical Trials on Bupropion Hydrochloride Extended-release

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe