JRCT ID: jRCT2031200287
Registered date:06/01/2021
BP40283
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Schizophrenia |
Date of first enrollment | 08/04/2021 |
Target sample size | 220 |
Countries of recruitment | United States,Japan,Spain,Japan,Ukraine,Japan |
Study type | Interventional |
Intervention(s) | RO6889450:150 mg or 300 mg QD placebo:QD |
Outcome(s)
Primary Outcome | Efficacy BNSS |
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Secondary Outcome | Safety, Efficacy, Phamacokinetics CGI-S, CGI-I, PANSS, BNSS, DPAS, Observation, PK |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 55age old |
Gender | Both |
Include criteria | 1. Patients with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder as confirmed by the MINI 2. Stable treatment with a D2/5HT2A antagonist or pure D2 antagonists, or a D2 partial agonist for a minimum of six months and receiving no more than two antipsychotics 3. Medically stable during the prior three months 4. Participant is an outpatient with no psychiatric hospitalizations within the prior six months 5. PANSS-NSFS of 18 or higher 6. The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control) 7. Has an informant who is considered reliable by the Investigator 8. BMI between 18-40 kg/m2 inclusive 9. A woman is eligible to participate if she is not pregnant, not breastfeeding, and 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. Moderate to severe substance use disorder within six months (excluding nicotine) as defined by DSM-5 2. Any ESRS-A CGI subscore greater than or equal to 3 3. Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder) 4. PANSS item G6 (depression) greater than or equal to 5 5. Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment 6. A prior or current general medical condition that might be impairing cognition or other psychiatric functioning 7. Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-2. HCV antibody positive participants are eligible if HCV RNA is negative 8. Tardive dyskinesia that is moderate to severe or requires treatment 9. History of neuroleptic malignant syndrome 10. 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 11. Clinically significant abnormalities in laboratory safety test results 12. Significant or unstable physical condition that in the investigator's judgment might require a change in medication or hospitalization during the course of the study 13. On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening 14. History of clozapine treatment 15. History of treatment with electroconvulsive therapy (ECT) 16. Concomitant use of prohibited medications 17. Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates 18. Receipt of an investigational drug within 28 days or five times the half-life of the investigational drug (whichever is longer) before the first study drug administration 19. Donation of blood over 400 mL within three months prior to screening 20. Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to Investigator and/or institutional approval to enroll |
Related Information
Primary Sponsor | Clinical trials information |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT03669640 |
Contact
Public contact | |
Name | Clinical trials information |
Address | 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120-189-706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | Clinical trials information |
Address | 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120-189-706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |