Actively Recruiting
Brexpiprazole Treatment for Bipolar I Depression
Led by Douglas Mental Health University Institute · Updated on 2024-08-07
58
Participants Needed
3
Research Sites
194 weeks
Total Duration
On this page
Sponsors
D
Douglas Mental Health University Institute
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Brexpiprazole Treatment for Bipolar I Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Male or female
- Diagnosis of bipolar disorder type I or type II
- Currently experiencing a treatment-resistant depressive episode lasting between 2 and 52 weeks
- Montgomery-Åsberg Depression Rating Scale (MADRS) score of 24 or higher with reported sadness score of 3 or higher
- Failed at least one treatment for the current depressive episode
- If female and of childbearing potential, using an adequate method of contraception
- Currently treated with a mood stabilizer such as lithium, valproate, lamotrigine, or quetiapine (100 mg/day or less)
- Normal laboratory test results including CBC, ferritin, electrolytes, thyroid, kidney function, hemoglobin A1c, lipid profile, and prolactin
- Normal electrocardiogram (EKG) at screening
- Able to provide informed consent
You will not qualify if you...
- High suicide risk as indicated by MADRS or clinical assessment
- Current hypomanic or manic episode with Young Mania Rating Scale (YMRS) score of 8 or higher
- Psychotic symptoms with YMRS content score of 4 or higher or as assessed clinically
- Treatment with fluoxetine, carbamazepine, risperidone, olanzapine, quetiapine over 100 mg/day, ziprasidone, or other antipsychotics
- Pregnant, breastfeeding, or not using contraception if of childbearing potential
- Drug abuse or dependence according to DSM-V criteria
- Unstable medical or untreated psychiatric conditions including hypothyroidism, hyperthyroidism, diabetes, cardiac issues, or hypertension
- Deficiency in vitamin B12 or folate
- Rapid cycling bipolar disorder (more than 4 mood episodes per year)
- History of difficulty swallowing
- Uncontrolled seizures
- Orthostatic hypotension
- Significant cardiovascular disease or arrhythmias
- Low white blood cell count
- Known eye disease
- Involuntary irregular muscle movements
- Known allergy to Brexpiprazole or its components
- Lactose intolerance or related hereditary conditions
- Active inflammatory diseases such as lupus, colitis, Crohn's disease, psoriasis, or irritable bowel syndrome
- Mild or major neurocognitive disorder
- Sensitivity or low tolerance to medications metabolized by CYP 2D6 inhibitors or CYP 3A4 inducers
- Contraindications for MRI including pacemaker, metal implants, claustrophobia, or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
McMaster University
Hamilton, Ontario, Canada, L8S 4L8
Terminated
2
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Withdrawn
3
Douglas Mental Health University Institute
Montreal, Quebec, Canada, H4H 1R3
Actively Recruiting
Research Team
N
Nada Khalil, BA
CONTACT
P
Paola Lavin Gonzalez, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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