The emerging epidemiology of hypomania and bipolar II disorder.
J Angst
https://pubmed.ncbi.nlm.nih.gov/9858074Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID04569448
Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study
Led by Douglas Mental Health University Institute · Updated on 2024-08-07
58
Participants Needed
3
Research Sites
N/A
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
Researchers are studying bipolar disorder, a chronic mood condition marked by recurring depressive episodes that are often resistant to treatment. This trial focuses on improving depressive symptoms and cognitive deficits, which significantly impact daily functioning and quality of life. The study evaluates Brexpiprazole, a medication with unique dopamine and serotonin receptor activities, to see if it can enhance mood, cognition, and brain structure in individuals with bipolar I and II depression. Participants will receive an adjunctive, variable dose of Brexpiprazole ranging from 1 to 3 mg per day. The treatment is added to existing mood stabilizers such as lithium, valproate, lamotrigine, or low-dose quetiapine. The study is open-label and will monitor effects over 8 weeks, with assessments continuing up to 6 months to observe changes in mood, cognitive function, and brain imaging. During the trial, participants will undergo evaluations including mood rating scales, cognitive tests, blood tests, and MRI scans. Researchers will track changes in depressive symptoms, global functioning, cognition, and biomarkers like C-reactive protein. Safety assessments will monitor adverse events and the risk of mood switching. The entire observation period includes assessments at 8 weeks, 12 weeks, and 6 months to evaluate both short-term and longer-term effects.
CONDITIONS
Brief Title
Brexpiprazole Treatment for Bipolar I Depression
Who Can Participate
Age: 18Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Male or female
- Diagnosed with Bipolar Disorder type I or type II
- Experiencing a treatment-resistant depressive episode lasting at least 2 weeks but no more than 52 weeks
- 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 low-dose quetiapine (100 mg/day or less)
- Laboratory values within normal limits including blood counts, electrolytes, thyroid, kidney function, hemoglobin A1c, lipids, and prolactin
- Normal EKG at screening
- Able to give informed consent
You will not qualify if you...
- High risk of suicide as assessed by MADRS or investigator opinion
- Current hypomanic or manic episode with YMRS score 8 or higher
- Presence of psychotic symptoms
- Treatment with fluoxetine or carbamazepine
- Treatment with risperidone, olanzapine, quetiapine over 100 mg/day, ziprasidone, or other antipsychotics
- Pregnant, lactating, or not using contraception if applicable
- Drug abuse or dependence
- Unstable medical or psychiatric conditions such as untreated hypothyroidism, diabetes, cardiac issues, or neurocognitive disorders
- Deficiency in vitamin B12 or folate
- Rapid cycling (more than 4 mood episodes per year)
- Difficulty swallowing
- Uncontrolled seizures
- Orthostatic hypotension
- History of significant cardiovascular disorders or arrhythmias
- Low white blood cell count
- Known eye disease or involuntary muscle movements
- Hypersensitivity to Brexpiprazole or its components
- Lactose intolerance or related metabolic disorders
- Active inflammatory diseases like lupus, colitis, Crohn's disease, psoriasis, or IBS
- Previous sensitivity to medications metabolized by CYP 2D6 or CYP 3A4
- MRI exclusion if pacemaker, metal implants, claustrophobia, or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive adjunctive variable dose Brexpiprazole treatment for bipolar depression.
Weekly visits for up to 8 weeks
Follow-up
Duration - Up to 6 months
Participants are monitored for safety, treatment effects, and cognitive function after treatment ends.
Visits at 12 weeks and 6 months post-treatment
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
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Research Team
N
Nada Khalil, BA
P
Paola Lavin Gonzalez, MD, MSc
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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Published Research Related To This Trial
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Gordon Parker
https://pubmed.ncbi.nlm.nih.gov/18777228Five-year outcome of bipolar I and II disorders: findings of the Jorvi Bipolar Study.
Sanna Pallaskorpi, Kirsi Suominen, Mikko Ketokivi...
https://pubmed.ncbi.nlm.nih.gov/25726951The long-term natural history of the weekly symptomatic status of bipolar I disorder.
Lewis L Judd, Hagop S Akiskal, Pamela J Schettler...
https://pubmed.ncbi.nlm.nih.gov/12044195The predictive significance of neurocognitive factors for functional outcome in bipolar disorder.
Christina Andreou, Vasilis P Bozikas
https://pubmed.ncbi.nlm.nih.gov/23154642Assessing and addressing cognitive impairment in bipolar disorder: the International Society for Bipolar Disorders Targeting Cognition Task Force recommendations for clinicians.
K W Miskowiak, K E Burdick, A Martinez-Aran...
https://pubmed.ncbi.nlm.nih.gov/29345040Incidence and predictors of suicide attempts in bipolar I and II disorders: A 5-year follow-up study.
Sanna Pallaskorpi, Kirsi Suominen, Mikko Ketokivi...
https://pubmed.ncbi.nlm.nih.gov/28176421Avoidable mortality in people with schizophrenia or bipolar disorder in England.
U Hoang, M J Goldacre, R Stewart
https://pubmed.ncbi.nlm.nih.gov/23216065Sleep and circadian alterations in people at risk for bipolar disorder: A systematic review.
Matias Carvalho Aguiar Melo, Raquel Fernandes Garcia, Vicente Bezerra Linhares Neto...
https://pubmed.ncbi.nlm.nih.gov/27661417Medications Used for Cognitive Enhancement in Patients With Schizophrenia, Bipolar Disorder, Alzheimer's Disease, and Parkinson's Disease.
Wen-Yu Hsu, Hsien-Yuan Lane, Chieh-Hsin Lin
https://pubmed.ncbi.nlm.nih.gov/29670547