A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)

What Was Tested

This registered phase 1 trial tested Neuropeptide Y.

It had two arms (groups): NPY/placebo (experimental) and placebo/NPY (experimental).

This arm gets placebo (saline) first then NPY.

The registry classes the interventions as drug.

Who Took Part

26 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Men and women, age 18-60. Participants must fulfill DSM-IV criteria for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS). CAPS score must be at least 40 (moderate PTSD severity) at screening.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: current, primary axis i disorders other than ptsd; history or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder); current diagnosis of anorexia nervosa or bulimia nervosa.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

Each person switched between Neuropeptide Y and the comparison at some point, usually with a gap in between.

As a double-blind Neuropeptide Y study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2012-12 with completion listed for 2016-01.

It ran at 1 site in United States.

What Was Measured

Researchers chose this as the main measure: Patient Rated Inventory of Side Effects (PRISE) (time frame: baseline and within 2 hours of administration of NPY).

It also tracked 2 secondary outcomes, for example State-Trait Anxiety Inventory (STAI) and Change in Beck Anxiety Inventory (BAI).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Neuropeptide Y in 26 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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