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Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

NCT00552760 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-04-14

Study results available
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Summary

The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.

Conditions

Interventions

DRUG

Ramelteon

one 8 mg tablet at bedtime for up to 6 months

DRUG

Placebo

one tablet at bedtime for up to 6 months

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Lehigh Valley Hospital

    lead OTHER

Principal Investigators

  • Edward R. Norris, MD · Lehigh Valley Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • United States

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 NCT00552760 on ClinicalTrials.gov