A Long-term Trial of OPC-34712 in Patients With Schizophrenia

Otsuka

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: OPC-34712

Study type: Interventional

Funder types: Industry

Identifiers

NCT01456897

331-10-003

JapicCTI-111632 (Other Identifier)

Details and patient eligibility

About

To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
• Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible

Exclusion criteria

• Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
• Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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282 participants in 1 patient group

OPC-34712

Experimental group

Treatment:

Drug: OPC-34712