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Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance

NCT00585208 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-05-10

No results posted yet for this study

Summary

The purpose of this research study is to evaluate the safety and efficacy of ramelteon (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This study will determine whether or not the addition of ramelteon to ongoing medication(s) for bipolar disorder is useful in improving sleep.

Conditions

Interventions

DRUG

Ramelteon

Ramelteon 8mg daily

DRUG

Placebo

matching placebo for ramelteon 8mg daily

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • University of Cincinnati

    collaborator OTHER

  • Lindner Center of HOPE

    lead OTHER

Principal Investigators

  • Susan L McElroy, MD · The Lindner Center of HOPE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00585208 on ClinicalTrials.gov