Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Intervention: Brexpiprazole; Placebo
Intervention description: Brexpiprazole tablets 1 to 4 mg /day; Placebo comparator for 52 weeks
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 524.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo
      as maintenance treatment in adults with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 years or older to less than 65 years, inclusive (at time of informed
             consent)

          -  Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
             and a history of the illness for at least three years prior to screening (as per
             subject, family, healthcare provider, or by previous medical records).

          -  Subjects with a stable living environment, as demonstrated by the ability to provide
             contact information for themselves and/or family/friend(s)/caregiver(s).

          -  Subjects who showed previous response to antipsychotic treatment in the past year.

          -  Subjects who are currently treated with oral or depot antipsychotics other than
             clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic
             treatment with antipsychotic medication for stabilization.

          -  Subjects who are experiencing a current acute exacerbation of psychotic symptoms
             requiring stabilization

          -  Subjects with a history of relapse and/or exacerbation of symptoms when they are not
             receiving antipsychotic treatment.

        Exclusion Criteria:

          -  Female patients who are breastfeeding or who have a positive pregnancy test (urine)
             result prior to receiving investigational medicinal product

          -  Patients presenting a first episode of schizophrenia based on the clinical judgment of
             the investigator

          -  Patients who are diagnosed with a disease other than schizophrenia (schizoaffective
             disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder,
             anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on
             current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder
             (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

          -  Subjects experiencing acute depressive symptoms within the past 30 days

          -  Subjects with schizophrenia who are considered resistant/refractory to antipsychotic
             treatment by history

          -  Subjects with a significant risk of violent behavior; who represent a risk of
             committing suicide

          -  Subjects with clinically significant tardive dyskinesia

          -  Subjects currently treated with insulin for diabetes.