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Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder

NCT01467713 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2016-05-16

Study results available
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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.

Conditions

Interventions

DRUG

Ramelteon SL

Ramelteon sublingual (SL) tablets

DRUG

Placebo

Ramelteon sublingual (SL) placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States
  • Argentina
  • Chile
  • Colombia
  • Mexico

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01467713 on ClinicalTrials.gov