Sexual Functioning Study With Antidepressants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316160
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

Brief Summary:
Effects of two depression medication on sexual functioning

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

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  (Clinical Trial)
Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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 Start Date : September 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Bupropion Hydrochloride Extended-release Drug: Extended-release Venlafaxine
    Other Name: Bupropion Hydrochloride Extended-release

Primary Outcome Measures :
  1. 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 :
  1. Efficacy, Safety, Tolerability, Health Outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316160

  Hide Study 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
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Burbank, California, United States, 91506
GSK Investigational Site
La Mesa, California, United States, 91942
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San Francisco, California, United States, 94109
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Temecula, California, United States, 92591
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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
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Coral Springs, Florida, United States, 33065
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Jacksonville, Florida, United States, 32216
GSK Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
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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
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Charlotte, North Carolina, United States, 28209
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44109
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Toledo, Ohio, United States, 43623
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
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Eugene, Oregon, United States, 97401
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Portland, Oregon, United States, 97209
GSK Investigational Site
Portland, Oregon, United States, 97210
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
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications of Results:
Responsible Party: GlaxoSmithKline Identifier: NCT00316160     History of Changes
Other Study ID Numbers: 100368
First Posted: April 20, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
sexual dysfunction

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine Hydrochloride
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors