Brexpiprazole in Patients With Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
To determine the safety and efficacy of brexpiprazole during long-term treatment.
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.
We found this trial at
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