Analyzing Female Trauma Exposed Responses to a Medication

• Status: Completed
• Trial end date: 2014-10-31
• Target enrollment: 0
• Participant gender: Female

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 health symptoms in comparison to placebo (an inactive substance).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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