A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2018

At a glance

  • Drugs Cariprazine (Primary)
  • Indications Bipolar I disorders
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Allergan; Forest Laboratories
  • Most Recent Events

    • 03 Apr 2018 According to the Allergan media release, company plans to include data from this and other two pivotal trials (700202873 and 700267733) in the Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2018.
    • 18 Dec 2017 Results presented in an Allergan Media Release.
    • 18 Dec 2017 According to an Allergan media release, primary endpoint has been met. (Change from Baseline Montgomery-sberg Depression Rating Scale (MADRS))
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