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Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071600
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Westchester Medical Center
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Esther Sabban, New York Medical College

Brief Summary:

Level 2 trauma patients admitted to Westchester Medical Center who consent and meet the inclusion criteria will answer a questionnaire, be tested on Beck Anxiety Index, assessed for vital signs and provide blood and urine samples for biomarker testing. before the intervention.

Part 1 Dose Escalation: Subjects will receive a single infusion NPY or vehicle delivered to the upper nasal cavity with an intranasal device. The administration of intranasal NPY will follow the 3 plus 3 model and Fibonacci dose escalation scheme.

Subjects will be assessed for Acute Stress Disorder (ASD) on the National Stressful Events Survey Acute Stress Disorder Sheet (NSESSS) at 3-7 and at 14-30 days post trauma, At >60 days post trauma to be evaluated with the PTSD Symptom Scale Interview for DSM-5 (PSS-I-5) and given the Beck Anxiety Inventory test.

Part 2 Dose Expansion Cohort: Once the maximal tolerated dose (MTD) is determined, we will follow it by a dose expansion cohort to obtain preliminary evidence of efficacy of intranasal NPY to alter the severity of ASD and inhibit the progression to PTSD and the usefulness of several biomarkers.


Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic, Acute Drug: Neuropeptide Y Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder (ASD)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Type two trauma patients randomly assigned to be administered the vehicle (water) with Kurve intranasal device once and followed for up to 60 days afterwards for development of Acute Stress Disorder and Posttraumatic Stress Disorder.
Other: Placebo
intranasal
Other Name: vehicle

Active Comparator: Neuropeptide Y
The individuals in this arm will be randomly assigned to be administered intranasal NPY with Kurve intranasal device once and will be followed for at least 60 days afterwards for development of Acute Stress Disorder and Posttraumatic Stress Disorder.
Drug: Neuropeptide Y
Intranasal

No Intervention: Control
The individuals in this arm will be randomly assigned and treated the same as the other arms but with no intervention.



Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 6-9 months ]
    Dose escalation until treatment emergent adverse effect

  2. Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for PTSD [ Time Frame: 2-3 years ]
    Rating for likely PTSD on PSS-I-5 a 20 item interview >60 days after the trauma

  3. Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for early Acute Stress Disorder (ASD) [ Time Frame: 2-3 years ]
    Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 3-7 days after traum

  4. Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for prolonged Acute Stress Disorder (ASD) [ Time Frame: 2-3 years ]
    Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 14-30 days after trauma


Secondary Outcome Measures :
  1. Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for anxiety [ Time Frame: 2-3 years ]
    Scores on Beck Anxiety Inventory (BAI)

  2. Preliminary indication of usefulness of blood pressure to predict development of ASD and PTSD and response to intranasal NPY [ Time Frame: 3 years ]
    Blood pressure measured sitting and standing

  3. Preliminary indication of usefulness of urinary norepinephrine to predict development of ASD and PTSD and usefulness of intranasal NPY [ Time Frame: 3 years ]
    Urinary norepinephrine levels by ELISA

  4. Preliminary indication of usefulness of plasma ACTH to predict development of ASD and PTSD and response to intranasal NPY [ Time Frame: 3 years ]
    Plasma ACTH by ELISA

  5. Preliminary indication of usefulness of epigentic changes in GR and NET genes to predict development of ASD and PTSD and response to intranasal NPY [ Time Frame: 3 years ]
    Methylation of the genes for glucocorticoid receptor (GR) and Norepinephrine Transporter (NET)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Level 2 trauma patients admitted to the trauma floors or trauma ICU at Westchester Medical Center
  • Experienced fear at the time of the trauma

Exclusion Criteria:

  • Vulnerable populations, such as pregnant women, prisoners, persons with decisional incapacity.
  • History of coronary artery disease, heart failure, prior stroke, heart surgery
  • Bood pressure >160/90
  • Acutely psychotic
  • Current diagnosis of anorexia nervosa, bulimia
  • Current diagnosis of cancer
  • Drug abuse or dependence in the preceding 3 months,
  • Any unstable medical condition
  • Active suicidal/homicidal ideation
  • Cannot speak, read, write and understand English at least at 8th grade level.

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): NCT04071600


Contacts
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Contact: Esther L Sabban, PhD 9145944068 sabban@nymc.edu
Contact: Yvette Smolin, MD 9144931310

Locations
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United States, New York
New York Medical College
Valhalla, New York, United States, 10595
Contact: Esther L Sabban, PhD         
Westchester Medical Center
Valhalla, New York, United States, 10595
Sponsors and Collaborators
New York Medical College
Westchester Medical Center
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Esther Sabban, PhD New York Medical College
Principal Investigator: Rhea Dornbush, PhD New York Medical College
Principal Investigator: Yvette Smolin, MD Westchestr Medical Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Esther Sabban, Professor, New York Medical College
ClinicalTrials.gov Identifier: NCT04071600    
Other Study ID Numbers: 13038
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Esther Sabban, New York Medical College:
neuropeptide Y
intranasal
biomarkers
anxiety
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic, Acute
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders