Effect of BI 1358894 on Cholecystokinin-Tetrapeptide (CCK-4)-Induced Anxiety, Panic Symptoms, and Stress Biomarkers: A Phase I Randomized Trial in Healthy Males

What Was Tested

This randomized controlled trial paper looks at Cholecystokinin (CCK) in the context of anxiety and panic.

Depression, anxiety, and/or panic disorder are often comorbid and have a complex etiology mediated through the same neuronal network.

Cholecystokinin-tetrapeptide (CCK-4), a synthetic analog of the endogenous neuropeptide cholecystokinin (CCK), is thought to be implicated in this network.

Who Took Part

PubMed tags the participants as men only.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and crossover study.

Because people in this Cholecystokinin (CCK) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Cholecystokinin (CCK).

The comparison arm used a placebo, so changes seen with Cholecystokinin (CCK) could be set against what happens without it.

In the crossover set-up each of the participants took both Cholecystokinin (CCK) and the comparison in turn, acting as their own control.

The primary endpoint was maximum change from baseline of the Panic Symptom Scale (PSS) sum intensity score after CCK-4 injection.

Further endpoints included the emotional faces visual analog score (EVAS), the Spielberger State-Trait Anxiety Inventory (STAI), plasma adrenocorticotropic hormone (ACTH), and serum cortisol values.

The safety and tolerability of BI 1358894 was assessed based on a number of parameters including occurrence of adverse events (AEs).

What Was Measured

PubMed files the paper under topics including Adrenocorticotropic Hormone, Anxiety, Biomarkers, Hydrocortisone, Tetragastrin and Organic Chemicals.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cholecystokinin (CCK) in people with anxiety and panic.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2023 (CNS drugs), a journal based in New Zealand.

More context: the Cholecystokinin (CCK) compound page, Anxiety and panic research.