MedTrace Logo

Brexpiprazole Treatment for Bipolar I Depression

NCT04569448 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-08-07

No results posted yet for this study

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

Interventions

DRUG

Brexpiprazole

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

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Jewish General Hospital

    collaborator OTHER

  • Douglas Mental Health University Institute

    lead OTHER

Principal Investigators

  • Serge Beaulieu, MD, PhD, FRCPC, DFAPA · Douglas Mental Health University Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04569448 on ClinicalTrials.gov