Status:
COMPLETED
Brexpiprazole in Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To determine the safety and efficacy of brexpiprazole during long-term treatment.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01810783
Start Date
July 1 2013
End Date
December 1 2015
Last Update
March 27 2017
Active Locations (48)
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US010
Anaheim, California, United States
2
US020
Cerritos, California, United States
3
US009
Escondido, California, United States
4
US022
Garden Grove, California, United States