BP40283
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2031200287
- Lead Sponsor
- Clinical trials information
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 220
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>BNSS
- Secondary Outcome Measures
Name Time Method Safety, Efficacy, Phamacokinetics<br>CGI-S, CGI-I, PANSS, BNSS, DPAS, Observation, PK