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

Phase 1

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: Neuropeptide Y

• Registration Number: NCT01533519
• Lead Sponsor: James Murrough

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Study Start: 2012-12
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo/NPY	Neuropeptide Y	This arm gets placebo (saline) first then NPY.
NPY/placebo	Neuropeptide Y	This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY.

Primary Outcome Measures

Name	Time	Method
Patient Rated Inventory of Side Effects (PRISE)	baseline and within 2 hours of administration of NPY	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States