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New treatment option for Bipolar Depression
Official title Brexpiprazole Treatment for Bipolar I Depression
ClinicalTrials.gov ID: NCT04569448
What this study is testing
What is Brexpiprazole?
Brexpiprazole is an investigational medicine, being studied as a potential treatment for bipolar depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Patient
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- Patient
- 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...
- 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)...
- Normal EKG at Screening
- Patient is able to give his(her) consent Patient
- 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...
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.