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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Collaborators: U.S. Army Medical Research and Development Command; Westchester Medical Center

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.