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.
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
- 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.