This trial is terminated!
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Your journey
1What's a trial
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3Review
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More info
You can access this
clinical trial
if you have
Acute Depressive Episode
and you are
between 18 and 75
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.

Provided treatments

  • Drug: Ramelteon SL
  • Drug: Placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01467700. The sponsor of the trial is Takeda and it is looking for 490 volunteers for the current phase.
Official trial 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