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Sexual Functioning Study With Antidepressants
This study has been completed.
First Received: April 18, 2006   Last Updated: May 15, 2009   History of Changes
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

Resource links provided by NLM:


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
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

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

  Show 45 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:
Depression
MDD
sexual dysfunction

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010