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

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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

Tracking Information
First Submitted Date  ICMJE January 31, 2012
First Posted Date  ICMJE February 15, 2012
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Change in Profile of Mood States (POMS) [ Time Frame: baseline and within 3 hours of administration of NPY ]
    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 ]
    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 ]
    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 ]
    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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Change in Systematic Assessment of Treatment-Emergent Effects (SAFTEE) [ Time Frame: baseline and within 3 hours of administration of NPY ]
  • Change in NPY levels in plasma [ Time Frame: at baseline and within 3 hours of administration of NPY ]
  • NPY levels in plasma [ Time Frame: repeated measures within 3 hours of administration of NPY ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)
Official Title  ICMJE A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE Drug: Neuropeptide Y
Intranasal administration will be administered with a nasal drug delivery device.
Other Name: NPY
Study Arms  ICMJE
  • 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
Publications * Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathé AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
20
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01533519
Other Study ID Numbers  ICMJE GCO 11-1487
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Murrough, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE James Murrough
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Murrough, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2016

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