Brexpiprazole in Patients With Schizophrenia

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01810783

14644B

2012-002705-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Brexpiprazole

Experimental group

Treatment:

Drug: Brexpiprazole