Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)

What Was Tested

In this phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The primary purpose of this randomized, double-blind, placebo-controlled cross-over study was to record and measure 40 Hz-auditory steady-state response (ASSR) in healthy controls (HC) and participants with mild-to-moderate schizophrenia (SZ) to determine if the mean inter-trial coherence (ITC) magnitude derived from the 40 Hz-ASSR is lower in SZ than in HC at baseline.

It had two arms (groups): Panel A: Healthy Control Participants (experimental) and Panel B: Participants with Mild-to-Moderate SZ (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a 2-part study.

Who Took Part

The registry lists 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Is in generally good health. Has no history of clinically relevant neuropsychiatric illness. Is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of \~10-15 cigarettes/day. Has a current diagnosis of SZ with a duration ≥1 year. Is clinically stable and in the residual (non-acute) phase of illness for ≥12 weeks prior to the study.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: has known biological family history of psychotic disorder in a first or second degree relative; may be excluded from participation by the investigator based on treatment history and/or performance on various screening tests; is positive for hepatitis b surface antigen, hepatitis c antibodies, or human immunodeficiency virus (hiv).

How the Study Was Run

Design: randomized, crossover and triple-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Therapeutic nicotine (patch, non-peptide) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

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

It started in 2022-04-27 with completion listed for 2022-09-23.

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

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Mean Inter-trial Coherence (ITC) Magnitude of 40 Hz-derived Auditory Steady-state Response (ASSR) in HC and SZ Participants at Baseline (time frame: Day -1 (Baseline)).

It also tracked 4 secondary outcomes, for example Duration Deviant Mismatch Negativity (DD-MMN) in HC and SZ Participants: MMN-A, N100-A, and P3A-A Tests, Duration Deviant Mismatch Negativity (DD-MMN) in HC and SZ Participants: MMN-L, N100-L, and P3A-L Tests, Effect of Nicotine on Mean ITC Magnitude of 40 Hz-derived ASSR in HC and SZ Participants Compared to Baseline and Plasma Nicotine Concentration 2 Hours After Patch Application (C2h) Assessed During Event Related Potential (ERP) Recording Sessions.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 38 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.