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Clinical Trial Summary

The primary purpose of this randomized, double-blind, placebo-controlled cross-over study is 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.


Clinical Trial Description

This is a 2-part study. Part 1 is a 2-period study in which participants receive 21 mg nicotine patches or placebo patches, each with placebo capsules, in Period 1 and Period 2 under a cross-over design. In Part 2 (Period 3), participants are randomized to receive either MK-4334 250 mg capsule or placebo capsule, each with placebo patches. ;


Study Design


Related Conditions & MeSH terms

  • Cognitive Impairment Associated With Schizophrenia
  • Schizophrenia

NCT number NCT05136690
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 1
Start date April 27, 2022
Completion date November 4, 2022

See also
  Status Clinical Trial Phase
Completed NCT03745820 - A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Phase 2
Active, not recruiting NCT00604760 - Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia Phase 2