Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Brexpiprazole
Intervention description: Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: schizophrenia; Mental Disorders; Psychotic Disorders; social avoidance; emotional withdrawal; passive/apathetic; social withdrawal; antipsychotic

Summary:

      The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole
      monotherapy in the improvement of early-episode schizophrenia through the assessment of
      social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as
      episodes occurring ≤ 5 years after the onset of the first episode.
    

Eligibility criteria:

        Inclusion Criteria: Have a diagnosis of schizophrenia as defined by the Diagnostic and
        Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and
        confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) for
        Schizophrenia and Psychotic Disorders Studies and an adequate clinical psychiatric
        evaluation.

          -  Had the start of their first schizophrenia episode ≤ 5 years before the time of
             consent.

          -  Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).

          -  Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening
             and baseline.

          -  Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to
             active social avoidance, emotional withdrawal, passive/apathetic social withdrawal,
             and difficulty in abstract thinking.

          -  Have a diagnosis of schizophrenia made at least 6 months prior to screening as
             confirmed by subject, caregiver, or documented history.

        Exclusion Criteria: Subjects presenting with a first episode of schizophrenia based on the
        clinical judgment of the investigator.

          -  Subjects who have been hospitalized for psychotic symptoms within the last 6 months.

          -  Subjects with schizophrenia who are considered resistant/refractory to antipsychotic
             treatment by history or who have a history of failure to respond to clozapine or
             response to clozapine treatment only.

          -  Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia,
             including, but not limited to, schizoaffective disorder, MDD, bipolar disorder,
             post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or
             other cognitive disorders. Also, subjects with borderline, paranoid, histrionic,
             schizotypal, schizoid, or antisocial personality disorders.

          -  Subjects experiencing acute depressive symptoms within the past 30 days, according to
             the investigator's opinion, that require treatment with an antidepressant.

          -  Subjects with clinically significant tardive dyskinesia at enrollment, as determined
             by a score of>= 3 on Item 8 of the AIMS at screening or baseline.

          -  Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment
             of akathisia at screening or baseline.

          -  Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the
             past 180 days; including alcohol and benzodiazepines, but excluding nicotine.