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Sexual Functioning Study With Antidepressants | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Sexual Functioning Study With Antidepressants

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

NCT00316160•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

Effects of two depression medication on sexual functioning

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (45)

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

Burbank, California, United States

GSK Investigational Site

La Mesa, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Temecula, California, United States

GSK Investigational Site

Upland, California, United States

Key Dates

Start Date

September 1, 2004

Primary Completion Date

May 1, 2005

Completion Date

May 1, 2005

Last Updated

May 30, 2017

Enrollment

347

Estimated participants

Conditions

Depressive Disorder, MajorMajor Depressive Disorder (MDD)

Interventions

Bupropion Hydrochloride Extended-release

DRUG

Extended-release Venlafaxine

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sexual Functioning Study With Antidepressants

Inclusion Criteria

Exclusion Criteria

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