A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2016

At a glance

  • Drugs Ramelteon (Primary)
  • Indications Bipolar I disorders
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Sponsors Takeda Global Research and Development Center
  • Most Recent Events

    • 07 Feb 2014 Planned number of patients changed from 870 to 618 as reported by ClinicalTrials.gov.
    • 24 Dec 2013 New source identified and integrated (United Kingdom Clinical Research Network : 12819)
    • 18 Jun 2013 Planned end date changed from 1 Nov 2014 to 1 Nov 2015 as reported by ClinicalTrials.gov record.
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