Health Condition 1: null- Schizophrenia Health Condition 2: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: OPC-34712: 1-6 mg/day, oral, for 6-week
Control Intervention1: NIL: NIL
Sponsors
Otsuka Pharmaceutical Development Commercialization
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 study 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 participated in 331-07-203 and who, in the opinion of the investigator, could potentially benefit from administration of OPC-34712 for the treatment of schizophrenia. Eligible subjects include those who completed participation in the Treatment Phase of Protocol 331-07-203 (ie, Week 6 visit), including subjects who initiated open-label OPC-34712 as rescue therapy at Week 4 or Week 5. 4.Outpatient status at last visit of Protocol 331-07-203.
Exclusion criteria
Exclusion criteria: 1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712. Target Disease, Medical History, and Concurrent Diseases 2.Subjects with a major protocol violation during the course of their participation in Protocol 331-07-203. 3.Subjects who do not continue to meet all applicable inclusion/ exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203. 4.Subjects who represent a risk of committing suicide. Prohibited Therapies or Medications 5.Subjects who would be likely to require prohibited concomitant therapy during the study Other 6.Any subject who, in the opinion of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary evaluation of safety and tolerability will be through frequency and severity of AEs. Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in PANSS Total Score Change from baseline in Clinical Global Impression - Severity of Illness scale (CGIS) score Change from baseline in Personal and Social Performance scale (PSP) Total Score Mean CGI-I score Change from baseline in PANSS positive subscale score Change from baseline in PANSS negative subscale score Response rate, defined as reduction of ≥ 30% from baseline in PANSS Total Score OR CGI-I score of 1 (very much improved) or 2 (much improved) ? Discontinuation rate for lack of efficacyTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactSuchela Srivatsa
IQVIA RDS (India) Private Limited
Outcome results
None listed