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

NCT04071600 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2019-08-28

No results posted yet for this study

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.

Conditions

  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic, Acute

Interventions

DRUG

Neuropeptide Y

Intranasal

OTHER

Placebo

intranasal

Sponsors & Collaborators

  • Westchester Medical Center

    collaborator OTHER

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • New York Medical College

    lead OTHER

Principal Investigators

  • Esther Sabban, PhD · New York Medical College

  • Rhea Dornbush, PhD · New York Medical College

  • Yvette Smolin, MD · Westchestr Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-10-31
Completion
2022-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071600 on ClinicalTrials.gov