Conditions: Acute Depressive Episode
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 490
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Based on the recommendation of the Independent Data Monitoring Committee which determined that the study data had met pre-determined criteria for futility, Takeda has made a decision to terminate the study. No safety concerns were identified by the Independent Data Monitoring Committee

Arms:
arm 1: Ramelteon SL 0.1 mg, tablets, sublingual (SL) \[dissolved under the tongue\], once daily (QD), every night at bedtime for up to 8 weeks. arm 2: Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 8 weeks. arm 3: Ramelteon SL 0.8 mg tablets, sublingual, once daily, every night at bedtime for up to 8 weeks. arm 4: Ramelteon SL placebo-matching, tablets, sublingual, once daily, every night at bedtime for up to 8 weeks.

Interventions: intervention 1: Ramelteon SL intervention 2: Placebo
Intervention descriptions: intervention 1: Ramelteon SL tablets intervention 2: Ramelteon placebo-matching tablets

Protocol document: