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

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