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Sexual Functioning Study With Antidepressants

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00316160
Collaborator
(none)
347
Enrollment
45
Locations
8
Duration (Months)
7.7
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effects of two depression medication on sexual functioning

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
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 :
Sep 1, 2004
Actual Primary Completion Date :
May 1, 2005
Actual Study Completion Date :
May 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 GSK Investigational Site Mesa Arizona United States 85210
2 GSK Investigational Site Phoenix Arizona United States 85023
3 GSK Investigational Site Scottsdale Arizona United States 85251
4 GSK Investigational Site Little Rock Arkansas United States 72223
5 GSK Investigational Site Beverly Hills California United States 90210
6 GSK Investigational Site Burbank California United States 91506
7 GSK Investigational Site La Mesa California United States 91942
8 GSK Investigational Site San Francisco California United States 94109
9 GSK Investigational Site Temecula California United States 92591
10 GSK Investigational Site Upland California United States 91786
11 GSK Investigational Site Walnut Creek California United States 94598
12 GSK Investigational Site Denver Colorado United States 80212
13 GSK Investigational Site Coral Springs Florida United States 33065
14 GSK Investigational Site Jacksonville Florida United States 32216
15 GSK Investigational Site Orlando Florida United States 32806
16 GSK Investigational Site Marietta Georgia United States 30060
17 GSK Investigational Site Smyrna Georgia United States 30080
18 GSK Investigational Site Oak Brook Illinois United States 60523
19 GSK Investigational Site Indianapolis Indiana United States 46202
20 GSK Investigational Site New Orleans Louisiana United States 70112
21 GSK Investigational Site Rockville Maryland United States 20852
22 GSK Investigational Site Braintree Massachusetts United States 02184
23 GSK Investigational Site Greenfield Massachusetts United States 01301
24 GSK Investigational Site Minneapolis Minnesota United States 55454
25 GSK Investigational Site Las Vegas Nevada United States 89146
26 GSK Investigational Site Brooklyn New York United States 11235
27 GSK Investigational Site New York New York United States 10128
28 GSK Investigational Site Charlotte North Carolina United States 28209
29 GSK Investigational Site Cleveland Ohio United States 44109
30 GSK Investigational Site Toledo Ohio United States 43623
31 GSK Investigational Site Oklahoma City Oklahoma United States 73112
32 GSK Investigational Site Oklahoma City Oklahoma United States 73117
33 GSK Investigational Site Eugene Oregon United States 97401
34 GSK Investigational Site Portland Oregon United States 97209
35 GSK Investigational Site Portland Oregon United States 97210
36 GSK Investigational Site Lincoln Rhode Island United States 02865-4208
37 GSK Investigational Site Charleston South Carolina United States 29407
38 GSK Investigational Site Columbia South Carolina United States 29201
39 GSK Investigational Site Austin Texas United States 78756
40 GSK Investigational Site Bellaire Texas United States 77401
41 GSK Investigational Site Fort Worth Texas United States 76107
42 GSK Investigational Site San Antonio Texas United States 78229
43 GSK Investigational Site Charlottesville Virginia United States 22908
44 GSK Investigational Site Yakima Washington United States 98902
45 GSK Investigational Site Middleton Wisconsin United States 53562-2215

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316160
Other Study ID Numbers:
  • 100368
First Posted:
Apr 20, 2006
Last Update Posted:
May 30, 2017
Last Verified:
May 1, 2017
Keywords provided by GlaxoSmithKline
sexual dysfunction
Depression
MDD
Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Bupropion
Venlafaxine Hydrochloride

Study Results

No Results Posted as of May 30, 2017