Trial Profile

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

Drugs Lurasidone (Primary)
Indications Bipolar I disorders
Focus Registrational; Therapeutic Use
Acronyms ELEVATE
Sponsors Sumitomo Dainippon Pharma

Most Recent Events

15 Sep 2020 Results of two randomized study (NCT00868699 and NCT01986101) assessing effect on core depressive symptoms, presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology.
22 Aug 2020 Primary endpoint ((MADRS)-80 - 120 mg/day group) has not been met, as per Results published in the Psychiatry and Clinical Neurosciences
22 Aug 2020 Results published in the Psychiatry and Clinical Neurosciences

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