Status:
COMPLETED
Analyzing Female Trauma Exposed Responses to a Medication
Lead Sponsor:
VA Office of Research and Development
Conditions:
Stress Disorders, Post-traumatic
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
This purpose of this study is to look at the safety of the experimental drug GSK561679 as well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress hormones, and mental healt...
Detailed Description
A growing body of literature suggests that stress-related disorders such as PTSD are associated with chronically increased activity of CNS circuits that utilize corticotropin-releasing factor (CRF), a...
Eligibility Criteria
Inclusion
- Female between 18-65 years of age
- Able to provide consent and willing to participate in research
- PTSD duration of illness at least 3 months
- Negative Urine toxicology test
- Agrees to use protocol-defined effective birth control method
Exclusion
- Subject is currently participating in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to PTSD, or 1 month for studies related to PTSD
- Subject has a documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis
- Subject requires ongoing treatment with medications that are prohibited per protocol
- Subject has a stool positive for occult blood.
- Pregnancy or lactation
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2014
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01814332
Start Date
January 1 2010
End Date
October 31 2014
Last Update
June 25 2021
Active Locations (1)
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1
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121