Acute Depressive Episode Clinical Trial
Official 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
The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult patients with acute depressive episodes associated with Bipolar I disorder.
Ramelteon sublingual formulation is being developed by Takeda Pharmaceutical Company Limited
for maintenance therapy of Bipolar I disorder.
Participants will be seen twice during the first week of treatment, weekly during the first
2 weeks of treatment and then every 2 weeks up to the end of the 8-week treatment period.
Participants who complete the 8-week treatment period will have a follow-up visit
approximately seven days after the last visit. A safety follow-up phone call will be made 30
days after completion of the 8-week treatment period.
After careful consideration and in consultation with the Data Monitoring Committee, Takeda
has made a decision to terminate this study. This is a business decision. There were no
safety or efficacy concerns.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment