BP41743

JRCT ID: jRCT2031200288

Registered date:06/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: schizophrenia
• Date of first enrollment: 13/07/2021
• Target sample size: 308
• Countries of recruitment: USA,Japan,Russia,Japan,Ukraine,Japan
• Study type: Interventional

Intervention(s)

RO6889450:45 mg or 150 mg QD
risperidone:4 mg QD (2 mg on Day 1)
placebo:QD

Outcome(s)

Primary Outcome

Efficacy
PANSS

Secondary Outcome

Safety, Efficacy, Phamacokinetics
PANSS, CGI-S, CGI-I, RDQ, Observation, PK

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Both

Include criteria

1. Participant must be 18 to 45 years of age inclusive
2. Participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder as confirmed by the MINI
3. Disease duration </=10 years
4. Have a current acute exacerbation of schizophrenia of no more than 8 weeks before screening visit and no current signs of apparent lack of treatment response
5. At the time of screening, the participant needs to be either hospitalized or requiring inpatient psychiatric care according to clinical judgment for the treatment of the acute exacerbation. If the participant has been hospitalized for the current exacerbation, the hospitalization has to be of a maximum of 1 week prior to screening.
6. In previous exacerbations and hospitalizations, the subject has shown a pattern of response to appropriate antipsychotic treatment
7. Medically stable over a period of 3 months (non-psychiatric conditions) prior to screening visit and not expected to require hospitalization or change of treatment for non-psychiatric conditions for the duration of the study
8. Screening and baseline CGI-S >=4 (moderate or worse)
9. Screening and baseline PANSS total score >= 80
10. Screening and baseline PANSS with scores of >= 4 (moderate or worse) on 2 or more of the following items: delusions, conceptual disorganization, unusual thought content, hallucinatory behavior, or suspiciousness/persecution
11. BMI between 18 and 35 kg/m2 inclusive
12. Male and female participants; a female agrees to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug

Exclude criteria

1. Has been inpatient for > 1 week or had any other hospitalization for acute exacerbation of schizophrenia or schizoaffective disorder within the prior 8 weeks or signs of lack of response to antipsychotic treatment
2. Disease duration longer than 10 years
3. Is currently an inpatient on an involuntary basis
4. The C-SSRS "Suicidal Ideation" item 4 or item 5 answered "Yes" or any "Yes" answers to "Suicidal Behavior" within one month from screening or between screening and baseline
5. Lifetime history of homicidal behavior
6. Moderate to severe substance use disorder within six months (excluding nicotine) as defined by DSM-5
7. Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
8. A prior or current general medical condition that might be impairing cognition or other psychiatric functioning
9. Clinically significant abnormalities in laboratory safety test results, including a) AST, OR ALT 2 x upper limit of normal (ULN), OR T-Bil > 1.5 ULN. b) Serum creatinine > 1.5 ULN
10. Positive result at screening for HBsAg, HCV, or HIV-1 and -2
11. Tardive dyskinesia that is moderate to severe or requires treatment
12. History of neuroleptic malignant syndrome
13. Average triplicate QTcF interval greater than 450 msec for males and 470 msec for females or other clinically significant abnormality on screening ECG based on centralized reading
14. Participant for whom risperidone is contraindicated or who have a documented history of lack of response or intolerance to risperidone or paliperidone or participants with known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperdal
15. Participant treated with a long acting injectable antipsychotic or other antipsychotics that cannot be washed-out within the allotted screening period
16. History of ECT for any reason
17. Participant treated with clozapine at any dose in the 12 months preceding the screening visit or participants treated with clozapine at 200 mg/day or above at any time
18. Participants currently receiving a psychotropic or other medication used as a psychotropic, which cannot be discontinued during the screening period
19. Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cocaine and barbiturates
20. Participant has previously received RO6889450
21. Participant received an investigational drug within 28 days or five times the half-life of the investigational drug prior to the first study drug administration
22. Diagnosis of COVID-19 infection 4 weeks prior to screening or during screening

Related Information

• Primary Sponsor: Clinical trials information
• Secondary ID(s): NCT04512066