Brexpiprazole for Bipolar Disorder
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications. You cannot participate if you are treated with fluoxetine, carbamazepine, risperidone, olanzapine, quetiapine (over 100mg/day), ziprazidone, or any other antipsychotic. However, you must be on a mood stabilizer like lithium, valproate, lamotrigine, or quetiapine (up to 100mg/day).
What data supports the idea that the drug Brexpiprazole for Bipolar Disorder is an effective treatment?
The available research shows that Brexpiprazole is effective for treating schizophrenia and as an additional treatment for major depressive disorder. It has been shown to improve symptoms and is generally well tolerated. However, there is no specific data provided about its effectiveness for treating Bipolar Disorder.12345
What safety data is available for Brexpiprazole?
Brexpiprazole, also known as Rexulti, is generally well tolerated with a relatively low incidence of activating and sedating adverse effects. It has been associated with moderate weight gain and small changes in metabolic parameters, which are not clinically significant. The most common adverse event is increased weight, with about 10% of patients gaining ≥7% body weight in short-term studies. Akathisia rates are low, and there are minimal effects on prolactin and the ECG QTc interval. Brexpiprazole is approved for schizophrenia and as an adjunct for major depressive disorder, with ongoing trials for other conditions.12346
Is the drug Brexpiprazole a promising treatment for Bipolar Disorder?
Research Team
Serge Beaulieu, MD
Principal Investigator
Douglas Mental Health University Institute
Eligibility Criteria
Adults aged 18-75 with Bipolar I Disorder currently experiencing treatment-resistant depression, who have tried at least one other treatment without success. Participants must be on a mood stabilizer and have normal heart function. They cannot join if they are at high suicide risk, have psychotic symptoms, certain neurocognitive disorders, uncontrolled seizures, known allergies to Brexpiprazole or its components including lactose intolerance.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Brexpiprazole
Find a Clinic Near You
Who Is Running the Clinical Trial?
Douglas Mental Health University Institute
Lead Sponsor
McMaster University
Collaborator
Jewish General Hospital
Collaborator