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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00316160 |
Purpose
Effects of two depression medication on sexual functioning
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder (MDD) |
Drug: Bupropion Hydrochloride Extended-release Drug: Extended-release Venlafaxine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
| Official Title: | See Detailed Description |
| Estimated Enrollment: | 344 |
| Study Start Date: | September 2004 |
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 |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations
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 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94109 | |
| GSK Investigational Site | |
| La Mesa, California, United States, 91942 | |
| GSK Investigational Site | |
| Upland, California, United States, 91786 | |
| GSK Investigational Site | |
| Burbank, California, United States, 91506 | |
| GSK Investigational Site | |
| Temecula, California, United States, 92591 | |
| 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 | |
| Jacksonville, Florida, United States, 32216 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| GSK Investigational Site | |
| Coral Springs, Florida, United States, 33065 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Smyrna, Georgia, United States, 30080 | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| 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 | |
| New York, New York, United States, 10128 | |
| GSK Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| 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, 73117 | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97209 | |
| GSK Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| 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 | |
| Fort Worth, Texas, United States, 76107 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78756 | |
| GSK Investigational Site | |
| Bellaire, Texas, United States, 77401 | |
| 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 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 100368 |
| Study First Received: | April 18, 2006 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00316160 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
|
Depression MDD sexual dysfunction |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions |
Behavioral Symptoms Serotonin Agents Mental Disorders Therapeutic Uses Venlafaxine Bupropion Mood Disorders Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |