A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)

Inclusion Criteria:

- Men and women, age 18-60.

- Participants must have a level of understanding sufficient to agree to all tests and
examinations required by the protocol and must sign a written informed consent
document. We determine whether they have a sufficient understanding of the study
procedures and risks by asking them to explain what's involved in the study and to
give examples of study risks and benefits.

- Participants must fulfill DSM-IV criteria for current PTSD, based on the Structured
Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the
Clinician-Administered PTSD Scale (CAPS).

- CAPS score must be at least 40 (moderate PTSD severity) at screening.

Exclusion Criteria:

- Current, primary Axis I disorders other than PTSD.

- History or current bipolar disorder or primary psychotic disorders (e.g.
schizophrenia, schizoaffective disorder).

- Current diagnosis of anorexia nervosa or bulimia nervosa.

- Women who are pregnant or are breast-feeding.

- Drug or alcohol abuse or dependence within the preceding 3 months.

- poorly controlled hypertension (manifest by SBP > 140 and/or DBP > 90); HR < 60 or >
100 at rest at the time of screening and confirmed immediately prior to randomization

- Evidence of coronary artery disease as evidenced by history, abnormal ECG, typical
symptoms

- History of arrhythmia, cardiac surgery, or family history of sudden death

- Hepatic dysfunction as defined by AST and ALT > 2x URL, or alkaline phosphatase and
bilirubin > 1.5 x URL within X days prior to randomization

- Chronic renal disease as defined by serum creatinine > 1.9

- Any other serious or unstable clinically significant abnormal findings of laboratory
parameters, physical examination, or ECG as determined by the PI.

- Any other serious or unstable condition that would put the subjects at undue risk as
determined by the PI or additional safety monitor.

- Serious and imminent suicidal or homicidal risk.

- Psychotropic medication that will not be tapered off at least 7 days prior to
screening; withdrawal symptoms must be absent at the time of screening

- History of nasal disorders or sinonasal surgery, or significant nasal abnormalities
based on nasal exam.

- Received investigational intervention within 30 days prior to randomization