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Sexual Functioning Study With Antidepressants

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ClinicalTrials.gov Identifier: NCT00316160
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Effects of two depression medication on sexual functioning

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Major Depressive Disorder (MDD) Drug: Bupropion Hydrochloride Extended-release Drug: Extended-release Venlafaxine Phase 4

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Bupropion Hydrochloride Extended-release
  • Drug: Extended-release Venlafaxine
    Other Name: Bupropion Hydrochloride Extended-release


Primary Outcome Measures :
  1. 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 :
  1. Efficacy, Safety, Tolerability, Health Outcome


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316160


  Show 45 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications of Results:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00316160     History of Changes
Other Study ID Numbers: 100368
First Posted: April 20, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
sexual dysfunction
Depression
MDD

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Venlafaxine Hydrochloride
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors