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

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    45
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 21 July 2022
Accepts healthy volunteers

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 schizophrenia (SZ) of mild-to-moderate severity 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.

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.

Details
Condition Cognitive Impairment Associated With Schizophrenia
Treatment Nicotine Patch, Placebo Capsule, Placebo Patch, MK-4334
Clinical Study IdentifierNCT05136690
SponsorMerck Sharp & Dohme LLC
Last Modified on21 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

HC Participants
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
Participants with SZ of Mild-to-Moderate Severity
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
Is stably maintained on a regimen of up to 2 first- or second-generation antipsychotics with no dose changes >50% in combination with concomitant medication commonly prescribed to this population for ≥8 weeks prior to screening and during the study
Is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of ~10-15 cigarettes/day
All Participants
For males, agrees to be abstinent from heterosexual intercourse, or use an approved contraception method, during the study and for 90 days after the last dose of study drug
For females, is not of childbearing potential
Is willing to comply with restrictions on the use of nicotine or nicotine-containing products during the study

Exclusion Criteria

HC Participants
Has known biological family history of psychotic disorder in a first or second degree relative
Participants with SZ of Mild-to-Moderate Severity
May be excluded from participation by the investigator based on treatment history and/or performance on various screening tests
All Participants
Is positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
Is at imminent risk of self-harm
Has had major surgery or donated blood within 4 weeks prior to screening
Has evidence of cognitive impairment or significant mental disability
Has a history of clinically significant abnormality or disease
Has a history of cancer (malignancy)
Is unable to refrain, or anticipates use, of any non-prescription drugs or herbal remedies
Has participated in another clinical study within 6 weeks or 5 half-lives (whichever is greater) prior to screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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