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Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

2014-08-27 04:00:29 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Acute Depressive Episode

Intervention

Ramelteon SL, Ramelteon SL, Ramelteon SL, Placebo

Location

Birmingham
Alabama
United States

Status

Recruiting

Source

Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:29-0400

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PubMed Articles [8131 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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