Phase 3
Completed N=282
A Long-term Trial of OPC-34712 in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01456897 ↗Enrolled (actual)
282
Serious AEs
13.2%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants With Adverse Events — 156; 79; 95; 38 Participants
◆ Published Evidence
Emerging
7citations · ~1 / year
Post-hoc analysis investigating the safety and efficacy of brexpiprazole in Japanese patients with schizophrenia who were switched from other antipsychotics in a long-term study (Secondary Publication).
Summary
To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.
Linked Publications
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Post-hoc analysis investigating the safety and efficacy of brexpiprazole in Japanese patients with schizophrenia who were switched from other antipsychotics in a long-term study (Secondary Publication).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
156; 79; 95; 38; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score |
-5.31; -7.20; -7.01; -9.44; -3.11; -2.58 | — |
| SECONDARY Mean Change From Baseline in PANSS Positive Subscale Score |
-1.09; -1.53; -1.13; -1.61; -0.19; 0.24 | — |
| SECONDARY Mean Change From Baseline in PANSS Negative Subscale Score |
-1.64; -1.49; -2.27; -2.02; -1.43; -0.89 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) |
-0.26; -0.20; -0.28; -0.15; -0.13; 0.03 | — |
| SECONDARY Mean Clinical Global Impression - Global Improvement(CGI-I) |
3.09; 3.16; 3.09; 3.22; 3.48; 3.86 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01456897) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.