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

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Neuropeptide Y.

It had three arms (groups): Placebo (placebo comparator), Neuropeptide Y (active comparator) and Control (no intervention).

The registry classes the interventions as drug and other.

More on the Plan

Every patient who consents to participate will fill out a questionnaire of general information including education level, marital status, social support etc. and administered the Beck Anxiety Inventory.

They will be asked to collect urine samples until the next morning.

The next morning at about 9-11 AM vital signs will be measured, including standing systolic blood pressure.

Blood and the overnight urine samples will be collected for biomarker testing.

Who Took Part

Enrollment: 117 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Experienced fear at the time of the trauma.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Neuropeptide Y group and the comparison group should start out alike.

The Neuropeptide Y group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Neuropeptide Y.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-11-01 with completion listed for 2022-10-31.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Safety and Tolerability (time frame: 6-9 months).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Neuropeptide Y in 117 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Neuropeptide Y compound page, all human trials.