A long-term trial of OPC-34712 in patients with schizophrenia
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080221592
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
ong-term administration of brexpiprazole had a sustained therapeutic effect, did not show any major results of safety concern, and was well tolerated. Long-term administration was possible in subjects aged 65 years or older, similar to subjects aged younger than 65 years. It was possible for patients to switch from therapy with prior antipsychotics to monotherapy with brexpiprazole within 4 weeks without any problems, and the condition remained stable even after switching.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 306
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
- 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 I criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of Participants With Treatment-emergent adverse event(TEAE)
- Secondary Outcome Measures
Name Time Method efficacy<br>1.Mean Change From Baseline to Week 6 in PANSS Total Score<br>2.Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score<br>3.Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score<br>4.Change in CGI-S Score from Baseline to Week 6<br>5.CGI-I Score at Week 6
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