CompletedInterventionalPhase 2Updated Oct 20, 2015
A Long-term Trial of OPC-34712 in Patients With Schizophrenia | NCT01456897 | Trialant
CompletedInterventionalPhase 3Updated Dec 30, 2019
A Long-term Trial of OPC-34712 in Patients With Schizophrenia
ClinicalTrials.gov ID
NCT01456897
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
282Actual
Last Update Posted
Dec 30, 2019Actual
Start Date
Oct 2011
Primary Completion Date
May 2015Actual
Brief Summary
To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.
Schizophrenia
OPC-34712
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)