Brexpiprazole for 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.

Timeline

Start

2017-03-01

Primary completion

2018-03-15

Completion

2018-03-15

Publications

• Scala M, Biondi L, Fabbri C, Serretti A. Efficacy of Brexpiprazole Combination Therapy on Anhedonia in a Case of Treatment Resistant Bipolar II Depression. J Clin Psychopharmacol. 2023 Sep-Oct 01;43(5):453-455. doi: 10.1097/JCP.0000000000001732. Epub 2023 Jul 14. No abstract available.

Drugs

Indications