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

A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Drug: Neuropeptide Y

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: James Murrough

Publications and helpful links

General Publications

• Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathe AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109.

Helpful Links

• Mood and Anxiety Disorders Program

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (ESTIMATE): February 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: PTSD; Trauma; Neuropeptide Y; Intranasal Administration
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: GCO 11-1487