Generalized Anxiety Disorder
Conditions
Brief summary
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder
Interventions
DRUGescitalopram
Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
DRUGpexacerfont
Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
DRUGplacebo
Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Outpatient women ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02)
Exclusion criteria
* Males * Patients who report a history of inadequate response to three or more adequate trials of any selective Serotonin reuptake inhibitors (SSRIs) for GAD within the last three years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score) | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score | Week 8 |
| Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score | Week 8 |
Countries
United States
Outcome results
None listed