NCT05136690

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

A Randomized, Double-Blind, Placebo-Controlled, Cross-over Evaluation of Evoked Responses as Pharmacodynamic Biomarkers in Healthy Adults and Schizophrenic Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a 2-part study. Part 1 was a 2-period study in which participants received either 21 mg nicotine patches and then placebo patches or vice versa, with each patch co-administered with placebo capsules, in a counterbalanced order. In Part 2, participants were randomized to receive either MK-4334 250 mg capsule or placebo capsule, each with placebo patches.

Conditions

• Cognitive Impairment Associated With Schizophrenia

Interventions

Type	Name	Description
DRUG	Nicotine patch	Nicotine 21 mg transdermal nicotine patch.
DRUG	MK-4334	MK-4334 250 mg capsule taken by mouth.
DRUG	Placebo patch	Placebo patch.
DRUG	Placebo capsule	Placebo capsule taken by mouth.

Timeline

• Start date: 2022-04-27
• Primary completion: 2022-09-23
• Completion: 2022-11-04
• First posted: 2021-11-29
• Last updated: 2024-11-29
• Results posted: 2024-11-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study