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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01533519
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Patient Rated Inventory of Side Effects (PRISE) [ Time Frame: 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 :
  1. State-Trait Anxiety Inventory (STAI) [ Time Frame: 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

  2. Change in Beck Anxiety Inventory (BAI) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533519


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
James Murrough
Investigators
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Principal Investigator: James Murrough, MD Icahn School of Medicine at Mount Sinai
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: James Murrough, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01533519    
Other Study ID Numbers: GCO 11-1487
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by James Murrough, Icahn School of Medicine at Mount Sinai:
Neuropeptide Y
Intranasal Administration
PTSD
Trauma
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders