A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 576
Status: Active, Not Recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

December 2, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Meet the diagnostic criteria for schizophrenia according to the DSM\-5 ™.
•2\. Be currently experiencing active phase symptoms of schizophrenia (DSM\-5 ™ Criterion A).
•3\. Have an illness duration for schizophrenia of at least 1 year and \=15 years.
•4\. Be confirmed to be experiencing an acute episode of schizophrenia, as evidenced by ALL of the following:
•a. Onset of the current acute episode is \=4 weeks prior to screening
•b. Current symptoms represent a marked and substantial worsening compared with the participant’s usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability
•c. In need of increased psychiatric attention to treat worsening acute episode symptoms
•5\. Have a minimum PANSS total score of \=80 at screening.
•6\. Have a score of \=4 (moderate) in 2 or more of the following items in the positive subscale of the PANSS at screening: delusions, hallucinations, conceptual disorganization, suspiciousness; at least 1 must be hallucinations or delusions.
•7\. Have a CGI\-S score of \=4 (moderately ill) at screening and baseline.

•1\. Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis (for example, major depression) that is primarily responsible for the current symptoms and functional impairment.
•2\. Meets criteria for moderate to severe substance use disorder currently or within past 6 months prior to screening.
•3\. Has a known history of the following:
•a. Borderline personality disorder, antisocial personality disorder, or bipolar disorder
•b. Traumatic brain injury causing ongoing cognitive difficulties, Alzheimer’s disease or another form of dementia, or any chronic organic disease of the central nervous system
•c. Intellectual disability of a severity that would impact the ability of the participant to participate in the study
•4\. Has a current diagnosis of a psychotic disorder (other than schizophrenia), or a behavioral disturbance thought to be substance\-induced or due to substance abuse.
•5\. Has moderate or severe tardive dyskinesia according to the investigator.
•6\. Is or was under involuntary commitment for the current acute episode, because the participant is considered a danger to themselves or others.
•7\. Has committed an act of violence (assaultive behavior) \= 2 years prior to the screening visit.