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Clinical trial

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) in the Treatment of Acute Depressive Episodes Associated With Bipolar I Disorder in Adult Patients Who Are on Lithium and/or Valproate

NCT01467700 is registered in ClinicalTrials.gov with Takeda as lead sponsor.

NCT NCT01467700
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Registry record

As filed in ClinicalTrials.gov.

Title
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) in the Treatment of Acute Depressive Episodes Associated With Bipolar I Disorder in Adult Patients Who Are on Lithium and/or Valproate
Lead sponsor
Takeda
Phase
Phase 3
Overall status
Terminated
Start date
December 31, 2011
Completion date
March 31, 2015
Enrollment
490 (actual)
Sites
161

Conditions

As the registry lists them; a condition with its own page is linked.

acute depressive episode