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

• Status: Not yet recruiting
• Trial end date: 2022-06-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Nicotine

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

SZ Participants:

• Has a current diagnosis of schizophrenia 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 on a stable regimen of up to 2 first- or second-generation antipsychotic or other concomitant medication commonly prescribed to this population

• 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

SZ Participants:

• 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 prohibited prescription or non-prescription therapy

• Has participated in another clinical study within 6 weeks or 5 half-lives (whichever is greater) prior to screening