Brexpiprazole in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and efficacy of brexpiprazole during long-term treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Brexpiprazole

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.