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Effects Of Antidepressants On Sexual Functioning In Adults

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00051272
Collaborator
(none)
425
Enrollment
24
Locations
17
Duration (Months)
17.7
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the effects of two antidepression medications on sexual functioning.

Condition or Disease Intervention/Treatment Phase
  • Drug: Extended-release Bupropion Hydrochloride
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
425 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-blind Randomized Placebo-controlled Comparison of the Effects on Sexual Functioning of Extended-release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Jun 1, 2004
Actual Study Completion Date :
Jun 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score. []

Secondary Outcome Measures

  1. Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17. []

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) with current duration lasting 12 weeks but no greater than 2 years.

  • Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.

  • Subject must have normal orgasmic function and be willing to discuss with investigator.

Exclusion Criteria:

  • Subjects that have arousal or orgasm dysfunction.

  • Has previously failed to respond to two adequate trials of antidepressants in past 2 years.

  • Subject has other unstable medical disorders.

  • Subject has a positive urine test for illicit drug use at screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Phoenix Arizona United States 85015
2 GSK Investigational Site Scottsdale Arizona United States 85251
3 GSK Investigational Site Berkeley California United States 94709
4 GSK Investigational Site Middletown Connecticut United States 06457
5 GSK Investigational Site Wilmington Delaware United States 19808
6 GSK Investigational Site Washington District of Columbia United States 20037
7 GSK Investigational Site Orlando Florida United States 32806
8 GSK Investigational Site Marietta Georgia United States 30060
9 GSK Investigational Site Smyrna Georgia United States 30080
10 GSK Investigational Site Boise Idaho United States 83702
11 GSK Investigational Site Baton Rouge Louisiana United States 70808
12 GSK Investigational Site Braintree Massachusetts United States 02184
13 GSK Investigational Site Piscataway New Jersey United States 08854
14 GSK Investigational Site New York New York United States 10128
15 GSK Investigational Site Raleigh North Carolina United States 27609
16 GSK Investigational Site Cleveland Ohio United States 44106
17 GSK Investigational Site Oklahoma City Oklahoma United States 73118
18 GSK Investigational Site Nashville Tennessee United States 37203
19 GSK Investigational Site Bellaire Texas United States 77401
20 GSK Investigational Site San Antonio Texas United States 78229-3815
21 GSK Investigational Site San Antonio Texas United States 78229
22 GSK Investigational Site San Antonio Texas United States
23 GSK Investigational Site Salt Lake City Utah United States 84107
24 GSK Investigational Site Yakima Washington United States 98902

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, MD, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00051272
Other Study ID Numbers:
  • AK130927
First Posted:
Jan 8, 2003
Last Update Posted:
Mar 29, 2011
Last Verified:
Mar 1, 2011
Keywords provided by , ,
depression, sexual dysfunction, orgasm disorder, MDD
Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Bupropion

Study Results

No Results Posted as of Mar 29, 2011