Brexpiprazole for treating depression in bipolar disorder
Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study
This study is testing if adding Brexpiprazole to the treatment plan can help adults with bipolar disorder who are still feeling depressed after trying other medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Douglas Mental Health University Institute Academic / other |
| Locations | 3 sites (Hamilton, Ontario and 2 other locations) |
| Trial ID | NCT04569448 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Brexpiprazole as an adjunctive treatment for patients with treatment-resistant depressive episodes associated with Bipolar Disorder type I and II. The study aims to address both mood symptoms and cognitive deficits that significantly impact functionality and quality of life in individuals with bipolar depression. Participants will be adults aged 18-75 who have experienced a depressive episode lasting between 2 to 52 weeks and have not responded to at least one prior treatment. The trial will assess improvements in mood and cognitive functioning through various clinical measures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of Bipolar Disorder type I or II who are experiencing treatment-resistant depressive episodes.
Not a fit: Patients who do not have Bipolar Disorder or those who have not experienced treatment-resistant depressive episodes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve mood and cognitive function in patients with bipolar depression, enhancing their overall quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches using Brexpiprazole in treating unipolar depression, suggesting potential for success in bipolar depression as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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 of \>/= 3 to item 10 of MADRS and/or in the clinical opinion of the investigator * Hypo(mania) episode with YMRS \>/= 8 * Psychotic symptoms as defined by a score of \>/= 4 to item 8 (content) of YMRS and/or in the opinion of the investigator * Is treated with fluoxetine OR carbamazepine * Is treated with risperidone OR olanzapine OR quetiapine \> 100mg/day OR ziprazidone OR any other antipsychotic * Is pregnant or lactating or absence of contraceptive treatment * Drug abuse or dependence as per DSM-V (MINI) * Unstable medical condition * Other unstable and/or untreated psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension * Deficit in vitamin B12 or folate * Rapid cycling (more than 4 mood episodes per year) * Active or history of difficulty to swallow * Seizures not currently controlled with medications * Orthostatic hypotension defined as a drop in systolic blood pressure of at least 20 mmHg or of diastolic BP of at least 10 mmHg within 3 minutes of standing * A history of clinically significant cardiovascular disorders and cardiac arrhythmias * A low white blood cell count * Known eye disease * Involuntary, irregular muscle movements, especially in the face * Known hypersensitivity to Brexpiprazole and any components of its formulation * Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because Brexpiprazole and placebo tablets contain lactose (a disaccharide of glucose and galactose) * Active inflammatory disease including lupus, colitis, Crohn's disease, psoriasis, irritable bowel syndrome (IBS) * Mild or major neurocognitive disorder * Previous history of sensitivity/low tolerance to medications metabolized by CYP 2D6 inhibitors, or CYP 3A4 inducers Control Inclusion Criteria: * Age: 18-75 * Male or female * No current or past history of any psychiatric disorder * 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 * 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 Control Exclusion Criteria: * Alcohol or drug abuse * Deficit in vitamin B12 or folate * Seizures not currently controlled with medications * History of clinically significant cardiovascular disorders and cardiac arrhythmias * Mild or major neurocognitive disorder Patient/Control Exclusion Criteria for MRI: * Pacemaker * Heart/vascular clip * Metal prosthesis * Metal fragments in body * Transdermal patch * Aneurysm clip * Prosthetic valve * Claustrophobia * Pregnant
Where this trial is running
Hamilton, Ontario and 2 other locations
- McMaster University — Hamilton, Ontario, Canada (Terminated)
- Jewish General Hospital — Montreal, Quebec, Canada (Withdrawn)
- Douglas Mental Health University Institute — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Serge Beaulieu, MD, PhD, FRCPC, DFAPA — Douglas Mental Health University Institute
- Study coordinator: Nada Khalil, BA
- Email: nada.khalil.comtl@ssss.gouv.qc.ca
- Phone: 514 444 5397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.