Status:
COMPLETED
A Long-term Trial of OPC-34712 in Patients With Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT01456897
Start Date
October 1 2011
Last Update
December 30 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kanto Region, Japan