Status:
COMPLETED
A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT01451164
Start Date
October 1 2011
Last Update
October 3 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kanto Region, Japan