Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334… (NCT05136690) | Clinical Trial Compass
CompletedPhase 1
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
United States38 participantsStarted 2022-04-27
Plain-language summary
The primary purpose of this randomized, double-blind, placebo-controlled cross-over study was 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 …
What they're measuring
1
Mean Inter-trial Coherence (ITC) Magnitude of 40 Hz-derived Auditory Steady-state Response (ASSR) in HC and SZ Participants at Baseline