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

Study Overview
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Brief Summary
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This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group.

Official Title
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A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Neuropeptide Y


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPY/placebo<br>This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY. | Drug: Neuropeptide Y<br>* Intranasal administration will be administered with a nasal drug delivery device.<br>* Other names: NPY;|
| Experimental: placebo/NPY<br>This arm gets placebo (saline) first then NPY. | Drug: Neuropeptide Y<br>* Intranasal administration will be administered with a nasal drug delivery device.<br>* Other names: NPY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Rated Inventory of Side Effects (PRISE) | Clinician-administered and safety measures will take place right before and after the administration to identify and evaluate the tolerability of each possible symptom (from baseline to within 2 hours of NPY administration). | baseline and within 2 hours of administration of NPY | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) | Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY | baseline and within 2 hours of administration of NPY | 
| Change in Beck Anxiety Inventory (BAI) | Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY | at baseline and within 2 hours of administration of NPY | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropeptide Y, Intranasal Administration, PTSD, Trauma