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

This study is currently recruiting participants.
Verified December 2012 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Dennis Charney, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01533519
First received: January 31, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is designed to investigate the safety of intranasal administration of NPY using a single-dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group. In this study we are testing three doses of NPY --- 200 nmol, 330 nmol, 500 nmol.


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:

U.S. FDA Resources

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 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: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPY/placebo
This arm gets NPY first then placebo (saline).
 Drug: Neuropeptide Y
Intranasal administration of 200nmol, 330nmol, 500nmol Neuropeptide Y dissolved in saline
Other Name: NPY
Experimental: placebo/NPY
This arm gets placebo (saline) first then NPY.
 Drug: Neuropeptide Y
Intranasal administration of 200nmol, 330nmol, 500nmol Neuropeptide Y dissolved in saline
Other Name: NPY

Detailed Description:

There is growing evidence that neuropeptides act as neuronal messengers in the brain and have diverse functions that may include the regulation of mood and behavior. Numerous studies have shown that neuropeptide Y (NPY) plays an important role in reducing anxiety/depression and acute stress response. The therapeutic application of NPY for psychiatric disorders has been limited by difficult and unreliable penetration of the blood-brain barrier (BBB). However, recent data suggest that intranasal administration may provide means of effectively delivering certain neuropeptides to the brain. Studies have shown that intranasal administration of neuropeptides can result in an increase in cerebrospinal fluid within a 2-hour period. Intranasal administration of NPY also resulted in an elevation of plasma NPY levels in 2 hours. So far the highest dose of NPY given to human is 100 nmol via intranasal administration, and no noticeable side effects or neurobehavioral (e.g. anxiolytic) effects have been observed. It is unclear whether NPY at this dose is sufficient to reach central nervous system and induce neurochemical and neurobehavioral changes, and whether a higher dose of NPY will be the optimal dose that is both safe and effective. This study is designed to investigate the safety of intranasal administration of NPY using a single-dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group. In this study we are testing three doses of NPY --- 200 nmol, 330 nmol, 500 nmol.

Study Aim:

1) To evaluate the safety of ascending dosages of intranasal NPY in a symptomatic PTSD group.

Hypothesis: Intranasal NPY will be well-tolerated with minimal dose-limiting toxicities (DLTs) at our testing doses.

Exploratory Aim:

1) To investigate the anxiolytic effects of intranasal NPY in PTSD. Hypothesis: Intranasal NPY may produce anxiolytic effects at safe doses.

  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.
  • Serious, unstable history of or current illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinological, neurologic, immunologic, or hematologic diseases.
  • Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG.
  • Current use of any medications that may significantly influence study safety or results.
  • Serious and imminent suicidal or homicidal risk.
  • History of nasal disorders or sinonasal surgery, or significant nasal abnormalities based on nasal exam.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533519

Contacts
Contact: Gang Wu, MPhil 212-241-9336 gang.wu@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Gang Wu, MPhil     212-241-9336     gang.wu@mssm.edu    
Principal Investigator: James Murrough, MD            
Sponsors and Collaborators
Dennis Charney
Investigators
Principal Investigator: James Murrough, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Dennis Charney, Dean, 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 10, 2012
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 May 22, 2013