Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity
Condition: Schizophrenia With Impulsivity
MeSH terms: Schizophrenia; Impulsive Behavior
Intervention: Brexpiprazole
Intervention description: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Mental Disorders, Antipsychotic,; Psychotic disorder, Impulsivity

Summary:

      The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic
      resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by
      impulsive behavior.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are 18 to 65 years of age, inclusive, at the time of informed consent (outpatients
             only), with a diagnosis of schizophrenia as defined by Diagnostic and Statistical
             Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and
             confirmed by both the M.I.N.I. for Schizophrenia and Psychotic Disorders Studies, and
             an adequate clinical psychiatric evaluation.

          -  Have a CGI-S score of ≤ 4 (moderately ill) at screening and baseline.

          -  Have a score of ≤ 4 (moderate) on PANSS item G8 (uncooperativeness) at screening and
             baseline.

          -  Have a BIS-11 score of ≥ 50 at screening and baseline.

          -  Willing to discontinue all prohibited psychotropic medications to meet
             protocol-required washouts prior to and during the trial period.

          -  Are stable on their current oral antipsychotic medication (no changes within the last
             month) and are able to meet protocol-required washouts of their current antipsychotic
             medication.

          -  Have received previous outpatient antipsychotic treatment at an adequate dose (at
             least minimal recommended dose for the treatment of schizophrenia according to the
             manufacturer labeling) for an adequate duration (at least 6 weeks) and showed a
             previous good response to such antipsychotic treatment (other than clozapine) in the
             last 12 months, according to the investigator's opinion.

          -  Subjects with eyesight that is sufficient to be able to see visual displays, or
             correctable with magnet-compatible glasses or contact lenses.

          -  Subjects fluent in English

        Exclusion Criteria:

          -  Are presenting with schizophreniform or with a first episode of schizophrenia based on
             the clinical judgment of the investigator.

          -  Have been hospitalized for psychotic symptoms within the previous 6 months.

          -  Have a current DSM-IV-TR Axis I primary diagnosis other than schizophrenia, including,
             but not limited to, schizoaffective disorder, major depressive disorder, bipolar
             disorder, post-traumatic stress disorder, obsessive-compulsive disorder (OCD) or panic
             disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects
             with borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality
             disorders, or mental retardation.

          -  Have worsening of ≥ 20% in total PANSS score between the screening and baseline
             assessments.

          -  Experiencing a deterioration in clinical status or an acute exacerbation of
             schizophrenia in the opinion of the Investigator.

          -  Experiencing acute onset of clinically significant depressive symptoms within the past
             30 days, according to the investigator's opinion.

          -  Answer "Yes" on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation
             Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and
             whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the
             last 6 months, OR Answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal
             Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria
             for this C-SSRS Item 5 occurred within the last 6 months OR Answer "Yes" on any of the
             5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted
             attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria
             for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR
             who, in the opinion of the investigator, present a serious risk of suicide.

          -  Have a history of stroke.

          -  Contraindications to magnetic resonance imaging (MRI) such as metal prostheses,
             pacemakers, claustrophobia, movement disorders, waist circumference more than 56
             inches or head circumference more than 29 inches, color blindness, significant
             tremors, or history of head injury or prolonged unconsciousness