A Randomized, Double-Blind, Placebo-Controlled, Cross-over Evaluation of Evoked Responses as Pharmacodynamic Biomarkers in Healthy Adults and Schizophrenic Patients

4334-007

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.

2022-04-27

2022-09-23

2022-11-04

Completed

Early phase I

38

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}

2022-11-17