Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder
Public ClinicalTrials.gov record NCT04071600. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder (ASD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04071600
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 117 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2019
- Primary completion
- Oct 30, 2022
- Completion
- Oct 31, 2022
- Last update posted
- Aug 27, 2019
2019 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New York Medical College | Valhalla | New York | 10595 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04071600, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2019 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04071600 live on ClinicalTrials.gov.