Brexpiprazole in Patients With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Brexpiprazole; Quetiapine extended release
Intervention description: Once daily as tablets and capsules, orally; 2-4 mg/day, once daily, tablets, orally; 400-800 mg/day, once daily, encapsulated tablets, orally
Intervention MeSH terms: Quetiapine Fumarate; Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

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

Eligibility 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.