Brexpiprazole in Patients With Acute Schizophrenia

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

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

Details

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

Criteria

Inclusion Criteria:

• The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).

• The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.

• The patient is willing to be hospitalised from the Screening Visit through Week 6.

• The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.

• The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.

• The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

• The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.

• The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).

• The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).

• 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 clinically significant tardive dyskinesia or severe akathisia at enrolment.

• The patient has a history of neuroleptic malignant syndrome.

• The patient has any relevant medical history or current presence of systemic disease.

• The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.

• The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of brexpiprazole.

• 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.