Sexual Functioning Study With Antidepressants

Phase 4

Completed

• Conditions: Major Depressive Disorder (MDD); Depressive Disorder, Major

• Registration Number: NCT00316160
• Lead Sponsor: GlaxoSmithKline

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Efficacy, Safety, Tolerability, Health Outcome

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Middleton, Wisconsin, United States