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Brexpiprazole Treatment for Bipolar I Depression

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 years 6 months later Feb 2025 → Sep 2030
See other at-risk trials from Douglas Mental Health University Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Feb 2025 to Sep 2030
    • Study completion pushed from Feb 2025 to Dec 2030
    • Site contacts updated at 1 of 3 sites
    v11
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Notable Primary and study completion dates: Dec 2023 to Feb 2025
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 3 of 3 sites
    v9
  4. Notable Primary and study completion dates: May 2023 to Dec 2023v8
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2021 to May 10, 2021
    • Site details revised at 3 of 3 sites
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Start date: Feb 2021 to May 2021
    • Primary and study completion dates: Feb 2023 to May 2023
    v6
  2. Notable Start date: Dec 2020 to Feb 2021
    • Primary and study completion dates: Dec 2022 to Feb 2023
    • Eligibility criteria revised
    • Secondary endpoints: 23 to 32
    v5
  3. Minor Primary and study completion dates: Nov 2022 to Dec 2022
    • Start date: Nov 2020 to Dec 2020
    v4
  4. Minor Eligibility criteria expanded, about 260 wordsv3
  5. Notable Start date: Sep 2020 to Nov 2020
    • Primary and study completion dates: Sep 2022 to Nov 2022
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04569448
Lead Sponsor Douglas Mental Health University Institute
Collaborators: McMaster University, Jewish General Hospital
Conditions
(from sponsor)
Bipolar Depression
Related terms Bipolar Disorder, Depressive Disorder, Treatment-Resistant
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov