Brexpiprazole Treatment for Bipolar I Depression

NCT04569448 | Recruiting Phase 3 DMC

• 1 other identifier: RSS 5182913
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bipolar Depression

Keywords

Brexpiprazole; Treatment-resistant depression; Cognition; Functioning; Rest-Activity rhythm; Hippocampus; CRP

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Depressive Symptoms as Assessed by MADRS at 8 weeks

  Percentage of response to treatment, as defined by a 50% improvement of depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 8 weeks. The overall MADRS score ranges from 0 to 60, where a higher score indicates more severe depression.

  8 weeks

Secondary Outcomes (32)

• Change from Baseline Global Functioning as Assessed by FAST at 8 weeks

  8 weeks

• Change from Baseline Global Functioning as Assessed by FAST at 12 weeks

  12 weeks

• Change from Baseline Global Functioning as Assessed by FAST at 6 months

  6 months

• Change from Baseline Global Functioning as Assessed by CPFQ at 8 weeks

  8 weeks

• Change from Baseline Global Functioning as Assessed by CPFQ at 12 weeks

  12 weeks

Study Arms (1)

Patient

EXPERIMENTAL

Individuals diagnosed with Bipolar Disorder Type I or Type II and suffering a major depressive episode who will receive an adjunctive and variable dose of Brexpiprazole treatment

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

Adjunctive variable dose (1-3 mg/day) Brexpiprazole

Patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead
• McMaster University: collaborator
• Jewish General Hospital: collaborator

Study Sites (3)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

TERMINATED

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

WITHDRAWN

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

RECRUITING

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MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Treatment-Resistant

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

Study Officials

• Serge Beaulieu, MD, PhD, FRCPC, DFAPA

  Douglas Mental Health University Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada Khalil, BA

CONTACT

514 444 5397; nada.khalil.comtl@ssss.gouv.qc.ca

Paola Lavin Gonzalez, MD, MSc

CONTACT

438 389 8181; maria.lavingonzalez@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC, DFAPA, Medical Chief

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: September 29, 2020
• Study Start: May 10, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)