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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

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)