A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: OPC-34712

Study type: Interventional

Funder types: Industry

Identifiers

NCT01451164

331-10-002

JapicCTI-111631 (Other Identifier)

Details and patient eligibility

About

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Enrollment: 459 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
• Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
• Patients who are experiencing acute exacerbation of psychotic symptoms

Exclusion criteria

• Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
• Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

459 participants in 4 patient groups, including a placebo group

High dose

Experimental group

Treatment:

Drug: OPC-34712

Drug: OPC-34712

Drug: OPC-34712

Mid dose

Experimental group

Treatment:

Drug: OPC-34712

Drug: OPC-34712

Drug: OPC-34712

Low dose

Experimental group

Treatment:

Drug: OPC-34712

Drug: OPC-34712

Drug: OPC-34712

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo