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Trial record 2 of 16 for:    neuropeptide y

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 November 2014 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: November 10, 2014
Last verified: November 2014

January 31, 2012
November 10, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
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).
  • Change in Profile of Mood States (POMS) [ Time Frame: baseline and within 3 hours of administration of NPY ] [ Designated as safety issue: No ]
    Clinician-administered and self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic and antidepressant effects of intranasal administration of NPY (from baseline to within 3 hours of NPY administration).
  • Change in Beck Depression Inventory (Second Edition) (BDI-II) [ Time Frame: at baseline and within 3 hours of administration of NPY ] [ Designated as safety issue: No ]
    Clinician-administered and self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic and antidepressant effects of intranasal administration of NPY
  • Change in Beck Anxiety Inventory (BAI) [ Time Frame: baseline and within 3 hours of administration of NPY ] [ Designated as safety issue: No ]
    Clinician-administered and self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic and antidepressant effects of intranasal administration of NPY
  • Change in Appetite Scale [ Time Frame: at baseline and within 3 hours of administration of NPY ] [ Designated as safety issue: No ]
    Clinician-administered and self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic and antidepressant effects of intranasal administration of NPY
Complete list of historical versions of study NCT01533519 on ClinicalTrials.gov Archive Site
  • 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
  • Change in Systematic Assessment of Treatment-Emergent Effects (SAFTEE) [ Time Frame: baseline and within 3 hours of administration of NPY ] [ Designated as safety issue: Yes ]
  • Change in NPY levels in plasma [ Time Frame: at baseline and within 3 hours of administration of NPY ] [ Designated as safety issue: No ]
  • NPY levels in plasma [ Time Frame: repeated measures within 3 hours of administration of NPY ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Posttraumatic Stress Disorder
Drug: Neuropeptide Y
Intranasal administration will be administered with a nasal drug delivery device.
Other Name: NPY
  • Experimental: NPY/placebo
    This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY.
    Intervention: Drug: Neuropeptide Y
  • Experimental: placebo/NPY
    This arm gets placebo (saline) first then NPY.
    Intervention: Drug: Neuropeptide Y
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Sarah Horn 212-241-7910 sarah.horn@mssm.edu
United States
 
NCT01533519
GCO 11-1487
Yes
James Murrough, Mount Sinai School of Medicine
James Murrough
Not Provided
Principal Investigator: James Murrough, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP