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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014