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

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute

In brief

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.

Key facts

Study ID

NCT04071600

Run by

New York Medical College

People needed

117

Starts

2019-11-01

Expected to finish

2022-11-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• New York Medical College — Valhalla, New York, United States
• Westchester Medical Center — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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