This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of PTSD. The study is being conducted at 2 sites in the United States: a site at Emory University, and one at Mount Sinai School of Medicine. About 150 women outpatients aged 21 to 65 who currently suffer from PTSD will be enrolled. Study participation could last for up to about 12 weeks.
The study is divided into 4 phases:
Phase 1 (Screening): a 1 week no drug screening period to assess study eligibility.
Phase 2 (Pre-Treatment Testing Period): Eligible patients will be enrolled into a 1 week Testing Phase, which will include neuropsychological and neurophysiological testing as well as blood draws and electrocardiogram.
Phase 3 (Treatment Period): Eligible patients will be enrolled in a two-armed 6-week period of double-blind placebo-controlled acute treatment. All subjects who continue to meet eligibility criteria will be randomized to one of two groups: GSK561679 (at a fixed dose of 350 mg/day) or placebo. Randomization will be performed at a 1:1 ratio into two treatment groups. Neuropsychological and neurophysiological testing will be repeated after 5 weeks of the double-blind treatment period.
Phase 4 (Follow-up Period): Safety follow-up visits will be conducted 1 week and 1 month after the end of the treatment Phase 3.
1. Women between the ages of 21 and 65
2. Fulfills DSM-IV criteria for a primary diagnosis of Post-traumatic stress disorder (PTSD)
3. Duration of PTSD is at least 3 months
4. Able to read and speak English
5. For women of reproductive age, must use of an effective birth control method or abstinence for the duration
6. Clinician-administered PTSD Scale score at Screening and Randomization visits of ≥ 50 on the CAPS
7. For women who have a history of peptic ulcer disease (PUD) with known etiology, evidence of effective treatment was provided with full eradication of ulcers and symptoms must be provided.
1. Lifetime diagnosis of a psychotic disorder (including schizophrenia), disorder, bipolar disorder, or obsessive compulsive disorder.
2. Current or past month participation in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device.
3. A current significant unstable medical illness or organic brain impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of GSK561679.
4. Patients who in the investigator’s judgment pose a current suicid