Conditions: Bipolar Disorder
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 642
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.

Detailed description:
TAK-375SL (ramelteon sublingual formulation) is being developed by Takeda Pharmaceutical Company Limited as an adjunctive treatment in the maintenance therapy of bipolar I disorder.

Participants will be seen twice a month for the first two months and then once every month up to the end of the 9-month treatment period. Participants who complete the 9-month treatment period will have a follow-up visit approximately seven days after the last visit. A safety followup phone call will be made 30 days after completion of the 9-month 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 placebo-matching, tablets, sublingual (SL) \[dissolved under the tongue\], once daily, every night at bedtime for up to 9 months. arm 2: Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months. arm 3: Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months. arm 4: Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.

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

Protocol document: