Sexual Functioning Study With Antidepressants
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316160
First received: April 18, 2006
Last updated: February 13, 2013
Last verified: February 2013
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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:
Drug Information available for:
Bupropion hydrochloride
Bupropion
Venlafaxine
Venlafaxine hydrochloride
U.S. FDA Resources
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:
Detailed Description:
-
Drug: Bupropion Hydrochloride Extended-release
Drug: Extended-release Venlafaxine
- Bupropion Hydrochloride Extended-release
- Extended-release Venlafaxine
Other Names:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316160
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Hide Study LocationsLocations
| 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 Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Antidepressive Agents Venlafaxine Bupropion Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Dopamine Uptake Inhibitors Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013