Brexpiprazole for Bipolar Depression

Completed · Phase 4

Conditions studied: Bipolar Depression

In brief

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.

Key facts

Study ID

NCT03427892

Run by

University of Texas Southwestern Medical Center

People needed

21

Starts

2017-03-01

Expected to finish

2018-03-15

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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