Major Depressive Disorder (MDD)
Conditions
Keywords
depression, MDD, sexual dysfunction, orgasm disorder
Brief summary
The purpose of this trial is to study the effects of two depression medications on sexual functioning.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S. | — |
Countries
United States
Outcome results
None listed