RecruitingPhase 3NCT04569448

Brexpiprazole Treatment for Bipolar I Depression

Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study

Sponsor

Douglas Mental Health University Institute

Enrollment

58 participants

Start Date

May 10, 2021

Study Type

INTERVENTIONAL

Conditions

Bipolar Depression

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called brexpiprazole can help people with Bipolar I or II disorder who are currently going through a depressive episode that hasn't improved with previous treatments. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with Bipolar I or Bipolar II disorder - You are currently experiencing a depressive episode lasting 2 weeks to 12 months that has not responded to at least one prior treatment - You are already taking a mood stabilizer (such as lithium, valproate, or lamotrigine) - Your blood tests and heart tracing (ECG) are within normal range - If you can become pregnant, you are using reliable contraception **You may NOT be eligible if...** - You are currently at high risk of suicide - You are experiencing a manic or hypomanic episode - You are taking fluoxetine, carbamazepine, risperidone, olanzapine, or other antipsychotics - You are pregnant or breastfeeding - You have a substance use disorder, unstable medical conditions, or rapid cycling (more than 4 mood episodes per year) - You have a known allergy to brexpiprazole or lactose intolerance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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