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

Sponsor

James Murrough (Other)

Overall Status

Completed

CT.gov ID

NCT01533519

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Drug: Neuropeptide Y	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Official Title:

A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: NPY/placebo

This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY.

Drug: Neuropeptide Y

Intranasal administration will be administered with a nasal drug delivery device.

Other Names:

NPY

Experimental: placebo/NPY

This arm gets placebo (saline) first then NPY.

Drug: Neuropeptide Y

Intranasal administration will be administered with a nasal drug delivery device.

Other Names:

NPY

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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