Brexpiprazole for Bipolar Depression

• Status: Completed
• Trial end date: 2018-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Brexpiprazole

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