Analyzing Female Trauma Exposed Responses to a Medication

Completed · Phase 2 · Has a placebo group

Conditions studied: Stress Disorders, Post-traumatic

In brief

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).

Key facts

Study ID

NCT01814332

Run by

VA Office of Research and Development

People needed

128

Starts

2010-01-01

Expected to finish

2014-10-31

Last updated by the study team

2021-06-25

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States

Full record on ClinicalTrials.gov

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