Brexpiprazole Treatment for Bipolar I Depression

What this study is about

Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of life in this clinical population. There is robust evidence that individuals with BD have neurocognitive deficits (especially in memory and executive functioning domains) compared to the healthy population. These deficits are present in all mood states and can greatly affect patients' functional capacity, often more so than mood symptoms themselves. Many pharmacological treatments for BD adversely affect cognition, and those that are beneficial can be difficult to use. There is thus a pressing need to identify a safe, easy-to-use medication that can target both cognitive deficits and depressive symptoms in BD. It is expected that Brexpiprazole adjunctive treatment will be efficacious in treating BD type I and type II depression by improving mood symptoms, as well as cognitive capacity and global functioning, and that such changes will be accompanied by concurrent alterations in associated brain structures.

Who can join (things the study team will check)

Patient Inclusion Criteria: * Age: 18-75 * Male or female * Bipolar Disorder type I or type II * Current treatment-resistant depressive episode (with MADRS \>/= 24 and item 2 (reported sadness) \>/= 3) for a minimum of 2 weeks but \</= 52 weeks at screening visit and baseline visit * Patients must have failed at least one other treatment for the current depressive episode * If female and of childbearing potential, is using an adequate method of contraception. Adequate methods of contraception include abstinence; oral contraceptive pill or surgically implanted device; intra-uterine device; condom plus spermicidal foam or jelly; or tubal ligation * Is treated with a mood stabilizer (lithium and/or valproate and/or lamotrigine and/or quetiapine \</= 100mg/day) * The following laboratory values are within normal limits at Screening: CBC with differential; ferritin; extended electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); thyroid function test(s); kidney function tests; hemoglobin A1c; lipid profile; prolactin * Normal EKG at Screening * Patient is able to give his(her) consent Patient Exclusion Criteria: * Is at high risk of suicide as defined by a score o…

Where this trial is running

• McMaster University, Hamilton, Ontario, Canada
• Jewish General Hospital, Montreal, Quebec, Canada
• Douglas Mental Health University Institute, Montreal, Quebec, Canada

Who to contact

Nada Khalil, BA · 514 444 5397 · nada.khalil.comtl@ssss.gouv.qc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04569448.