Clinical trial NCT00051272: Effects Of Antidepressants On Sexual Functioning In Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder (MDD)
Keywords: depression, sexual dysfunction, orgasm disorder, MDD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-01-08
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
Secondary outcomes:
measure: Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Berkeley
country: United States
facility: GSK Investigational Site
state: California
city: Middletown
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Wilmington
country: United States
facility: GSK Investigational Site
state: Delaware
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Smyrna
country: United States
facility: GSK Investigational Site
state: Georgia
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Braintree
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Piscataway
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Bellaire
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Yakima
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: