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

NCT04071600 | Unknown Phase 1 FDA Drug

• 1 other identifier: 13038
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

neuropeptide Y; intranasal; biomarkers; anxiety

Outcome Measures

Primary Outcomes (4)

• Safety and Tolerability

  Dose escalation until treatment emergent adverse effect

  6-9 months

• Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for PTSD

  Rating for likely PTSD on PSS-I-5 a 20 item interview \>60 days after the trauma

  2-3 years

• Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for early Acute Stress Disorder (ASD)

  Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 3-7 days after traum

  2-3 years

• Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for prolonged Acute Stress Disorder (ASD)

  Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 14-30 days after trauma

  2-3 years

Secondary Outcomes (5)

• Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for anxiety

  2-3 years

• Preliminary indication of usefulness of blood pressure to predict development of ASD and PTSD and response to intranasal NPY

  3 years

• Preliminary indication of usefulness of urinary norepinephrine to predict development of ASD and PTSD and usefulness of intranasal NPY

  3 years

• Preliminary indication of usefulness of plasma ACTH to predict development of ASD and PTSD and response to intranasal NPY

  3 years

• Preliminary indication of usefulness of epigentic changes in GR and NET genes to predict development of ASD and PTSD and response to intranasal NPY

  3 years

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Neuropeptide Y

ACTIVE COMPARATOR

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.

Drug: Neuropeptide Y

Control

NO INTERVENTION

The individuals in this arm will be randomly assigned and treated the same as the other arms but with no intervention.

Interventions

Neuropeptide Y DRUG

Intranasal

Neuropeptide Y

Placebo OTHER

intranasal

Also known as: vehicle

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• New York Medical College: lead
• Westchester Medical Center: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

New York Medical College

Valhalla, New York, 10595, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Related Publications (3)

• Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathe AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109.

  PMID: 29186416 BACKGROUND

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

  PMID: 38767196 DERIVED

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.

  PMID: 35141873 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute; Anxiety Disorders

Interventions

Neuropeptide Y

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Esther Sabban, PhD

  New York Medical College

  PRINCIPAL INVESTIGATOR

• Rhea Dornbush, PhD

  New York Medical College

  PRINCIPAL INVESTIGATOR

• Yvette Smolin, MD

  Westchestr Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther L Sabban, PhD

CONTACT

9145944068; sabban@nymc.edu

Yvette Smolin, MD

CONTACT

9144931310

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: November 1, 2019
• Primary Completion: October 31, 2022
• Study Completion: November 1, 2022
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)