Merck Sharp & Dohme LLC
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.
Cognitive Impairment Associated With Schizophrenia
Nicotine patch
MK-4334
Placebo patch
Placebo capsule
Phase 1
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 Type : | Interventional |
Estimated Enrollment : | 38 participants |
Masking: | Triple |
Primary Purpose: | Basic Science |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Cross-over Evaluation of Evoked Responses as Pharmacodynamic Biomarkers in Healthy Adults and Schizophrenic Patients |
Actual Study Start Date : | April 27, 2022 |
Estimated Primary Completion Date : | September 23, 2022 |
Estimated Study Completion Date : | November 4, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Panel A: Healthy Control Participants In Part 1, HC participants receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), HC participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo. |
Drug: Nicotine patch Drug: MK-4334 Drug: Placebo patch Drug: Placebo capsule |
Experimental: Panel B: Participants with Mild-to-Moderate SZ In Part 1, participants with mild-to-moderate SZ receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), SZ participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo. |
Drug: Nicotine patch Drug: MK-4334 Drug: Placebo patch Drug: Placebo capsule |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Collaborative Neuroscience Research, LLC ( Site 0002)
Long Beach, California, United States, 90806
Not yet recruiting
Hassman Research Institute Marlton Site ( Site 0001)
Marlton, New Jersey, United States, 08053