CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
Nicotine patch +3 moredrug
Likely dose
Nicotine patch 21 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05136690
NCT05136690Phase 1Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Nov 29, 2021·Updated Nov 29, 2024

In Brief

A Phase 1 clinical trial evaluating Nicotine patch, MK-4334, and 2 other interventions for Cognitive Impairment Associated With Schizophrenia. Completed, enrolled 38 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCognitive Impairment Associated With Schizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedNov 29, 2021
Enrollment StartApr 27, 2022
Primary CompletionSep 23, 2022
Study CompletionNov 4, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.6 years ago

Interventions

Nicotine patchdrug

Nicotine 21 mg transdermal nicotine patch.

MK-4334drug

MK-4334 250 mg capsule taken by mouth.

Placebo patchdrug

Placebo patch.

Placebo capsuledrug

Placebo capsule taken by mouth.