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A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) in the Treatment of Acute Depressive Episodes Associated With Bipolar I Disorder in Adult Patients Who Are on Lithium and/or Valproate.

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) in the Treatment of Acute Depressive Episodes Associated With Bipolar I Disorder in Adult Patients Who Are on Lithium and/or Valproate.

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Ramelteon (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

    • Most Recent Events

    • 09 Mar 2015 Status changed from recruiting to discontinued, as reported by ClinicalTrials.gov.
    • 28 Mar 2014 Planned End Date changed from 1 Nov 2013 to 1 May 2015 as reported by ClinicalTrials.gov.
    • 27 Aug 2012 Planned number of patients changed from 300 to 312 as reported by ClinicalTrials.gov.
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