A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adult Patients.

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-375SL as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adult Patients.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 27 May 2016

At a glance

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

    • 08 Apr 2016 The time frame of the primary endpoint has changed from month 9 to month12.
    • 01 Dec 2015 Planned End Date changed from 1 Sep 2015 to 1 Feb 2015, according to ClinicalTrials.gov record.
    • 01 Dec 2015 Planned primary completion date changed from 1 Sep 2015 to 1 Feb 2015, according to ClinicalTrials.gov record.
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