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.
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
- 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.