Sexual Functioning Study With Antidepressants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316160
First received: April 18, 2006
Last updated: February 13, 2013
Last verified: February 2013

April 18, 2006
February 13, 2013
September 2004
May 2005   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00316160 on ClinicalTrials.gov Archive Site
Efficacy, Safety, Tolerability, Health Outcome
Same as current
Not Provided
Not Provided
 
Sexual Functioning Study With Antidepressants
See Detailed Description

Effects of two depression medication on sexual functioning

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Depressive Disorder, Major
  • Major Depressive Disorder (MDD)
  • Drug: Bupropion Hydrochloride Extended-release
  • Drug: Extended-release Venlafaxine
    Other Names:
    • Bupropion Hydrochloride Extended-release
    • Extended-release Venlafaxine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
344
May 2005
May 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316160
100368
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP