NCT00051259

Brief Summary

The purpose of this trial is to study the effects of two depression medications on sexual functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

1.4 years

First QC Date

January 7, 2003

Last Update Submit

October 1, 2010

Conditions

Major Depressive Disorder (MDD)

Keywords

depressionMDDsexual dysfunctionorgasm disorder

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.

Secondary Outcomes (1)

  • Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.

Interventions

Extended-Release Bupropion HydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

GSK Investigational Site

Berkeley, California, 94709, United States

Location

GSK Investigational Site

Beverly Hills, California, 90210, United States

Location

GSK Investigational Site

La Mesa, California, 91942, United States

Location

GSK Investigational Site

Oceanside, California, 92056, United States

Location

GSK Investigational Site

Coral Springs, Florida, 33065, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Terre Haute, Indiana, 47802, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21208, United States

Location

GSK Investigational Site

Rockville, Maryland, 20852, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55454, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44109, United States

Location

GSK Investigational Site

Toledo, Ohio, 43623, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74135, United States

Location

GSK Investigational Site

Eugene, Oregon, 97401, United States

Location

GSK Investigational Site

Portland, Oregon, 97210, United States

Location

GSK Investigational Site

Lincoln, Rhode Island, 02865-4208, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29407, United States

Location

GSK Investigational Site

Bellaire, Texas, 77401, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22908, United States

Location

GSK Investigational Site

Richmond, Virginia, 23294, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionSexual Dysfunction, PhysiologicalSexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorGenital DiseasesUrogenital Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2003

First Posted

January 8, 2003

Study Start

January 1, 2003

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

US(23)