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Neuropeptide
Neuropeptide Y for Post-Traumatic Stress Disorder
Phase 1 & 2
Waitlist Available
Led By Rhea Dornbush, PhD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Level 2 trauma patients admitted to the trauma floors or trauma ICU at Westchester Medical Center
Experienced fear at the time of the trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 years
Awards & highlights
Study Summary
This trial is testing whether intranasal NPY can help people with Level 2 trauma who consent and meet the inclusion criteria by being tested on the Beck Anxiety Index, and providing blood and urine samples for biomarker testing. If successful, this could help people with Level 2 trauma by altering the severity of ASD and inhibiting the progression to PTSD.
Eligible Conditions
- Post-Traumatic Stress Disorder
- Acute Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for PTSD
Administration, Intranasal
Administration, Intranasal
+1 moreSecondary outcome measures
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for anxiety
Preliminary indication of usefulness of blood pressure to predict development of ASD and PTSD and response to intranasal NPY
Preliminary indication of usefulness of epigentic changes in GR and NET genes to predict development of ASD and PTSD and response to intranasal NPY
+2 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: ControlActive Control1 Intervention
The individuals in this arm will be randomly assigned and treated the same as the other arms but with no intervention.
Group II: Neuropeptide YActive Control1 Intervention
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.
Group III: PlaceboPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
5,944 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
245,042 Total Patients Enrolled
Westchester Medical CenterOTHER
7 Previous Clinical Trials
1,356 Total Patients Enrolled
Frequently Asked Questions
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