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Protocol 331-13-009: An Exploratory, Multicenter, Randomized, Double-Blind, fMRI Study of Fixed-dose Brexpiprazole (OPC-34712) (2 and 4 mg/Day Tablets) in Adults With Schizophrenia With Impulsivity

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Trial Profile

Protocol 331-13-009: An Exploratory, Multicenter, Randomized, Double-Blind, fMRI Study of Fixed-dose Brexpiprazole (OPC-34712) (2 and 4 mg/Day Tablets) in Adults With Schizophrenia With Impulsivity

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2020

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At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Schizophrenia
  • Focus Pharmacodynamics; Registrational
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 11 Jun 2020 Primary endpoint (Change from baseline brain activation in the VLPFC based on change from baseline to Week 6 in fMRI BOLD activation score in the right VLPFC during performance of the SSRT Task) has been met, according to results published in the Psychiatry Research - Neuroimaging
    • 11 Jun 2020 Primary endpoint (Change from baseline brain activation in the VLPFC based on change from baseline to Week 6 in fMRI blood oxygen-level dependent (BOLD) activation score in the right VLPFC during performance of the Go/No-go Task) has not been met, according to results published in the Psychiatry Research - Neuroimaging
    • 11 Jun 2020 Results published in the Psychiatry Research - Neuroimaging
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