Brexpiprazole for Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Brexpiprazole
Intervention description: Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
Intervention MeSH terms: Brexpiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: mood; bipolar; depression

Summary:

      The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole
      in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to
      assess if brexpiprazole is associated with a reduction in depressive symptom severity using
      the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an
      assessment of the following in patients with bipolar disorder taking brexpiprazole: manic
      symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life.

      Subjects will be discontinued from the study if any of the following conditions occurs:
      change in diagnosis to other than bipolar I or II disorder, development of active suicidal or
      homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of
      the investigators requires discontinuation, pregnancy, development of severe life-threatening
      medical condition, involuntary psychiatric hospitalization or incarceration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient men and women ages 18-65

          -  Bipolar I or II disorders, currently depressed mood state based on a SCID for DSM-5;
             Mixed features in DSM-5 are allowed, but those with a Young Mania Rating Scale score ≥
             15 will be excluded

          -  Baseline MADRS score ≥ 20

        Exclusion Criteria:

          -  Mood disorders other than bipolar I or II disorders (e.g., bipolar NOS, or cyclothymic
             disorders, schizophrenia, schizoaffective disorder, or unipolar depression based on
             the SCID), other disorders, e.g. anxiety disorders, will be allowed

          -  Current (last 14 days) treatment with an antipsychotic or antidepressant

          -  History of neuroleptic malignant syndrome or tardive dyskinesia

          -  Prior history of brexpiprazole use

          -  Vulnerable populations (e.g., pregnant, nursing, cognitively impaired, incarcerated)

          -  High risk for suicide defined as > 1 attempt in past 12 months that required medical
             attention, any attempt in the past 3 months or current suicidal ideation with plan and
             intent such that outpatient care is precluded

          -  Severe or life-threatening medical condition, or laboratory or physical examination
             findings consistent with serious medical illness (e.g., dangerously abnormal
             electrolytes)

          -  Moderate or severe hepatic or renal impairment based on medical history and laboratory
             analyses

          -  Taking moderate or strong induces or inhibitors of CYP2D6 or CYP3A4