Phase 3
Completed N=210
Brexpiprazole in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01810783 ↗Enrolled (actual)
210
Serious AEs
14.8%
Results posted
Feb 2017
Primary outcomePrimary: Safety and Tolerability — 337 TEAEs
◆ Published Evidence
Emerging
10citations · ~3 / year
Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies.
Summary
To determine the safety and efficacy of brexpiprazole during long-term treatment.
Linked Publications (2)
-
Effects of Brexpiprazole on Functioning in Patients With Schizophrenia: Post Hoc Analysis of Short- and Long-Term Studies.
-
Effects of Brexpiprazole Across Symptom Domains in Patients With Schizophrenia: <i>Post Hoc</i> Analysis of Short- and Long-Term Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability |
337 | — |
Eligibility Criteria
Inclusion Criteria
- The patient has completed the lead-in study 14644A.
- The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator.
- The patient agrees to protocol-defined use of effective contraception.
Exclusion Criteria
- The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A.
- The patient has a clinically significant unstable illness diagnosed during Study 14644A.
- The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
- The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01810783) 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.