EUCTR2020-000094-24-BG
Active, Not Recruiting
Phase 1
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 LLC
- Enrollment
- 500
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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 \=6 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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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