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

This study is currently recruiting participants.
Verified December 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
James Murrough, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01533519
First received: January 31, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Posttraumatic Stress Disorder
Drug: Neuropeptide Y
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Patient Rated Inventory of Side Effects (PRISE) [ Time Frame: baseline and within 2 hours of administration of NPY ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline and within 2 hours of administration of NPY ] [ Designated as safety issue: No ]
    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) [ Time Frame: at baseline and within 2 hours of administration of NPY ] [ Designated as safety issue: No ]
    Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY


Estimated Enrollment: 24
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: NPY

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533519

Contacts
Contact: Sarah Horn 212-241-7910 sarah.horn@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Sarah Horn    212-241-7910    sarah.horn@mssm.edu   
Principal Investigator: James Murrough, MD         
Sponsors and Collaborators
James Murrough
Investigators
Principal Investigator: James Murrough, MD Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: James Murrough, Assistant Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01533519     History of Changes
Other Study ID Numbers: GCO 11-1487
Study First Received: January 31, 2012
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Neuropeptide Y
Intranasal Administration
PTSD
Trauma

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014