Table 2 Inclusion and exclusion criteria

1

Female outpatients between 18 and 65 years old.

2

Primary psychiatric diagnosis of DSM-IV defined Posttraumatic Stress Disorder of at least three months duration.

3

Total CAPS past week and past month scores ≥ 50 at the screening and Visit 3 (randomization) visits.

4

Able to independently understand and provide written informed consent.

5

A negative urine toxicology.

6

For women of reproductive age, use of an effective birth control method^a for the duration of the study or abstinence.

7

Subjects who have a history of peptic ulcer disease with known etiology must provide documentation that effective treatment was provided with full eradication of ulcers and symptoms.

Exclusion criteria

1

Current 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 month prior to screening.

2

Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, central nervous system tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of GSK561679.

3

Subjects who in the investigator’s judgment pose a current suicidal or homicidal risk.

4

Diagnosis of anorexia nervosa or bulimia in the past year.

5

Use of systemic corticosteroids within two weeks of the Randomization Visit.

6

Treatment with any other psychoactive medication within two weeks of Visit 1, including all antidepressants, psychoactive herbal or nutritional treatment (St Johns Wort, SAM-e), lithium, other mood stabilizers, oral antipsychotics, depot antipsychotics within 12 weeks, beta blockers, thioridazine, pimozide, opiates, anxiolytics, and sedatives (with the exception of zolpidem, eszopiclone, and zaleplon). Also any treatment with any medication that the investigator judges not acceptable for this study.

7

Current pregnancy or lactation.

8

A positive stool test for occult blood.

9

Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures (for example, illiteracy, planned vacations, or planned hospitalizations during the study).

10

Previous treatment with CRF1 receptor antagonist.

11

Any laboratory abnormality that in the investigator’s judgment is considered to be clinically significant.

12

Current treatment with exposure-based psychotherapy that targets PTSD symptoms.

13

Current or planned litigation or other actions related to secondary gain regarding the traumatic event.

14

Any cardiac condition or ECG evidence that the investigator feels will predispose the subject to ischemia or arrhythmia.

15

ECG results indicating a QTc > 450 msec at either the Screening or Randomization Visit unless repeat ECG shows that the parameter had returned to within normal range by the Randomization Visit.