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NCT05136690 | Completed | Cognitive Impairment Associated With Schizophrenia


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

Merck Sharp & Dohme LLC

Brief 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.

Condition or disease

Cognitive Impairment Associated With Schizophrenia

Intervention/treatment

Nicotine patch

MK-4334

Placebo patch

Placebo capsule

Phase

Phase 1

Detailed 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 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
Criteria
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 Mild-to-Moderate SZ
      • 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 Mild-to-Moderate SZ
            • 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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, California

Collaborative Neuroscience Research, LLC ( Site 0002)

Long Beach, California, United States, 90806

Not yet recruiting

United States, New Jersey

Hassman Research Institute Marlton Site ( Site 0001)

Marlton, New Jersey, United States, 08053

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