Sexual Functioning Study With Antidepressants

NCT ID: NCT00316160

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-05-31

Brief Summary

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Effects of two depression medication on sexual functioning

Detailed Description

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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

Conditions

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Depressive Disorder, Major Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Bupropion Hydrochloride Extended-release

Intervention Type DRUG

Extended-release Venlafaxine

Intervention Type DRUG

Other Intervention Names

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Bupropion Hydrochloride Extended-release

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mesa, Arizona, United States

Site Status

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Burbank, California, United States

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La Mesa, California, United States

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San Francisco, California, United States

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Temecula, California, United States

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Upland, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Coral Springs, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Marietta, Georgia, United States

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Smyrna, Georgia, United States

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Oak Brook, Illinois, United States

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Indianapolis, Indiana, United States

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New Orleans, Louisiana, United States

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Rockville, Maryland, United States

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Braintree, Massachusetts, United States

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Greenfield, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Yakima, Washington, United States

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Middleton, Wisconsin, United States

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Countries

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United States

References

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Thase ME, Clayton AH, Haight BR, Thompson AH, Modell JG, Johnston JA. A double-blind comparison between bupropion XL and venlafaxine XR: sexual functioning, antidepressant efficacy, and tolerability. J Clin Psychopharmacol. 2006 Oct;26(5):482-8. doi: 10.1097/01.jcp.0000239790.83707.ab.

Reference Type RESULT
PMID: 16974189 (View on PubMed)

Other Identifiers

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100368

Identifier Type: -

Identifier Source: org_study_id

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