Initial Study Sesting Efficacy and Tolerability of PT150 for PTSD in Veterans

Exclusion Criteria

• •Severe alcohol or substance use disorders by DSM-5 criteria in past 3 months or positive urine test for substances other than cannabis
• •History or diagnosis of neurodegenerative disorders, psychotic disorders or bipolar disorder. Current treatment with antipsychotic medication for mental health
• •History of suicide attempts and/or current suicidal ideation with plan or intent
• •Currently using psychotropic medication (except SSRI/SNRI) or other drugs or agents which might interact with study drug. Currently taking SSRI/SNRI antidepressants for less than 30 days. Benzodiazepines or sleep agents (e.g. eszopiclone; zolpidem) are excluded; exception: trazodone 25-50 mg qhs prn for sleep or prazosin for nightmares
• •Be pregnant or nursing
• •HRT dose not stable for a minimum of 3 months
• •Evidence of a serious, chronic medical condition that would increase the risk of an adverse outcome or history of any serious metabolic or other disease known to affect the CNS
• •Have evidence of untreated or unstable medical illness including cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active HIV+/AIDS infection
• •Serious cognitive impairment likely to interfere with ability to meaningfully participate
• •Past brain injury/head trauma with minor loss of consciousness and current symptoms or significant loss of consciousness
• •Current signs of violence or aggression
• •A history of adrenal insufficiency or a plasma cortisol level ≤ 5 mcg/dl at screening
• •Receiving non-pharmacotherapy treatments or procedures for where precautions exist for taking with PT150 and/or those that might interfere with the study
• •Contraindication(s) to take PT150 such as renal or hepatic impairment, congenital metabolic disorders, or hypersensitivity to study drug or similar compounds
• •Participation in a pharmaceutical trial or use of investigational drugs within 1 month of screening
• •Hearing loss that would interfere with the extinction recall measures
• •Any other illness, condition, or use of medications which in the opinion of the PI and/or study investigator would preclude safe and/or successful completion of the study