Phase 2B Study of MK-8189 in Participants with an Acute Episode of Schizophrenia

JRCT ID: jRCT2071200096

Registered date:02/02/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 28/06/2021
• Target sample size: 40
• Countries of recruitment: USA,Japan,Russia,Japan,Ukraine,Japan,Poland,Japan,Latvia,Japan,Croatia,Japan,Bulgaria,Japan,Taiwan,Japan,South Korea,Japan
• Study type: Interventional
• Intervention(s): MK-8189/Risperidone/Placebo to MK-8189

Outcome(s)

Primary Outcome

- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
- Number of participants who experience one or more adverse events (AEs)
- Number of participants who discontinue study treatment due to an AE

Secondary Outcome

- Change from baseline in PANSS positive subscale (PSS) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
- Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6: MK-8189 24 mg, MK-8189 16 mg, or placebo
- Change from baseline in weight at Week 12: MK-8189 24 mg, MK-8189 16 mg, or risperidone
- Change from baseline in PANSS total score at Week 6: MK-8189 8 mg or placebo
- Change from baseline in weight at Week 6: MK-8189 24 mg, MK-8189 16 mg, MK-8189 8 mg or placebo

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

- Meet the diagnostic criteria for schizophrenia according to the DSM-5
- Have an illness duration for schizophrenia of at least 1 year and <=15 years
- 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
- Have a CGI-S score of =>4 (moderately ill) at screening and baseline
- Have an identified responsible person referred to as the "external contact person" who has agreed to provide information about the participant's location if needed during outpatient portion of the study. The site personnel must consider this identified responsible person a reliable contact person, and the contact person must have regular contact with the participant (defined at screening as direct contact no fewer than 3 times per week), and with the expectation that this frequency of contact would continue (either in person or via other contact method), throughout duration of the study, including the follow-up period)

Exclude criteria

- Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment
- Meets criteria for moderate to severe substance use disorder within past 6 months prior to screening (excluding those related to caffeine or nicotine)
- Has a known history of the following: (a) borderline personality disorder, anti-social 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 ability to participate in the study
- Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse
- Is or was under involuntary commitment for the acute episode, because the participant is considered a danger to themselves or others
- Has a history of treatment resistance exhibited by any of the following: (a) no or minimal response to at least 2 periods of treatment lasting 6 weeks or longer, with antipsychotic agents at the maximally tolerated dose. Participants who have responded to antipsychotics only when paired with clozapine are considered treatment resistant (b) history of electroconvulsive therapy (ECT) treatment for treatment resistant schizophrenia within the past 5 years (c) past or current use of clozapine as single or adjunctive therapy for schizophrenia within the past 5 years
- Is currently participating in or has participated in an interventional clinical research study within 12 months prior to the screening visit of this current study

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT04624243