Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Brexpiprazole (OPC-34712 ) 0.05-mg, 0.25-mg, 0.5-mg, 1-mg, 2-mg, 3-mg, 4-mg, 5-mg, 6-mg, and 25-mg tablets: Phase A: 1-2 mgs/day, orally once daily, maximum of 4 wks.
Phase B: 1-4 mg/da
Sponsors
Otsuka Pharmaceutical Development Commercialization Inc
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Rollover Subjects from Trial 331-10-230 and Trial 331-10-231 : 1. Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures. 2. Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales. 3. Subjects who completed 6 weeks of post-randomization treatment in Trial 331-10-230 or Trial 331-10-231and who, in the opinion of the investigator, could potentially benefit from monotherapy treatment with oral brexpiprazole for schizophrenia. 4. Male and female subjects 18 to 65 years of age, inclusive, at the time of informed consent for Trial 331-10-237. 5. Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231. Hospitalization for psychosocial reasons (eg, homelessness or need for shelter that is unrelated to the subjectâ??s underlying psychiatric condition) will be considered outpatient status for the purpose of enrollment in Trial 331-10-237. Subjects remaining in hospital at the Week 6 visit of Trial 331-10-230 or Trial 331-10-231 (for other than psychosocial reasons) will be permitted to enroll in Trial 331-10-237 at the Week 6 visit of the double-blind trial if they are planned to be discharged from the hospital before the Week 1 visit of Trial 331-10-237. Subjects not discharged by the Week 1 visit of Trial 331-10-237 must be withdrawn. Inclusion Criteria for Rollover Subjects from Trial 331-10-232: 1. Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures. 2. Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales. Subjects who, in the opinion of the investigator, could potentially benefit from administration of oral brexpiprazole for the treatment of schizophrenia and who meet one of the following criteria: a) completed the Double-blind Maintenance Phase (ie, Week 52 visit) of Trial 331-10-232; b) met criteria for exacerbation of psychotic symptoms/impending relapse during the Doubleblind Maintenance Phase (Phase C) of Trial 331-10-232 and were withdrawn from the trial; c) was participating in Phase A, B, or C of Trial 331-10-232 at the time of early trial termination due to a positive result from a planned interim analysis; or d) was participating in Phase A, B, or C of Trial 331-10-232 when the trial reached its conclusion of 90 impending relapse events. 3. Male and female subjects 18 to 65 years of age, inclusive, at the time of informed consent for Trial 331-10-237. 4. Inpatient or outpatient status at last visit of Trial 331-10-232. Additional Criteria Required for Entry Into Phase B of Trial 331-10-237 (Applies to subjects rolling over from Phase A of Trial 331-10-232 if the trial is terminated early or reaches its conclusion.) 5. Completed cross-titration from other antipsychotic medication(s), if applicable. 6. Completed washout of
Exclusion criteria
Exclusion criteria: 1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug 2.Subjects with a current DSM-IV-TR Axis I diagnosis of: â?¦Schizoaffective disorder â?¦MDD â?¦Bipolar disorder â?¦Delirium, dementia, amnestic or other cognitive disorder â?¦Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder 3.Subjects presenting with a first episode of schizophrenia 4.Other protocol specific exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of OPC-34712 to be assessed by examining the frequency and severity of adverse events.Timepoint: up to 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Clinical Global Impression -Severity of Illness scale scoreTimepoint: up to 52 weeks;Change in Personal and Social Performance scale Total ScoreTimepoint: up to 52 weeks;Change in Positive and Negative Syndrome Scale Positive Subscale, Negative Subscale and Total Scores.Timepoint: up to 52 weeks;Discontinuation rate for lack of efficacyTimepoint: up to 52 weeks;Improved Response rateTimepoint: up to 52 weeks;Mean Clinical Global Impression - Improvement scale scoreTimepoint: up to 52 weeks | — |
Countries
Argentina, Bulgaria, Canada, Chile, Colombia, Croatia, India, Japan, Latvia, Lithuania, Malaysia, Mexico, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Slovakia, South Africa, Taiwan, Ukraine, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research India Pvt. Ltd.
Outcome results
None listed