Sexual Functioning Study With Antidepressants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316160
First received: April 18, 2006
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

Effects of two depression medication on sexual functioning


Condition Intervention Phase
Depressive Disorder, Major
Major Depressive Disorder (MDD)
Drug: Bupropion Hydrochloride Extended-release
Drug: Extended-release Venlafaxine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • Efficacy, Safety, Tolerability, Health Outcome

Estimated Enrollment: 344
Study Start Date: September 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bupropion Hydrochloride Extended-release Drug: Extended-release Venlafaxine
    Other Names:
    • Bupropion Hydrochloride Extended-release
    • Extended-release Venlafaxine
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

  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)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316160

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85210
GSK Investigational Site
Phoenix, Arizona, United States, 85023
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72223
United States, California
GSK Investigational Site
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
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80212
United States, Florida
GSK Investigational Site
Coral Springs, Florida, United States, 33065
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
GSK Investigational Site
Smyrna, Georgia, United States, 30080
United States, Illinois
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
GSK Investigational Site
Braintree, Massachusetts, United States, 02184
GSK Investigational Site
Greenfield, Massachusetts, United States, 01301
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89146
United States, New York
GSK Investigational Site
Brooklyn, New York, United States, 11235
GSK Investigational Site
New York, New York, United States, 10128
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44109
GSK Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Portland, Oregon, United States, 97210
GSK Investigational Site
Portland, Oregon, United States, 97209
United States, Rhode Island
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29407
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Investigational Site
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
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
United States, Washington
GSK Investigational Site
Yakima, Washington, United States, 98902
United States, Wisconsin
GSK Investigational Site
Middleton, Wisconsin, United States, 53562-2215
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00316160     History of Changes
Other Study ID Numbers: 100368
Study First Received: April 18, 2006
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
sexual dysfunction
Depression
MDD

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Bupropion
Venlafaxine
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on September 16, 2014