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Sponsors and Collaborators: |
University of Cincinnati Takeda Global Research & Development Center, Inc. The Lindner Center of HOPE |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00585208 |
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.
Condition | Intervention | Phase |
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Insomnia Bipolar Disorder |
Drug: Ramelteon Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Add-On Ramelteon in Ambulatory Bipolar I Disorder With Clinically Significant Sleep Disturbance |
Estimated Enrollment: | 30 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Ramelteon
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Drug: Ramelteon
fixed dose of 8 mg daily at bedtime throughout the study
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2: Placebo Comparator
placebo
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Drug: placebo
taken daily at bedtime
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This is a randomized, double-blind, placebo-controlled, parallel-group, single site, 8-week trial of add-on ramelteon in outpatient adults (18-65 years old, inclusive) with lifetime bipolar I disorder, with mild to moderate manic symptoms, and currently experiencing a clinically significant sleep disturbance. Approximately 60 subjects will be screened to obtain 30 subjects who enroll in the 8-week trial. Subjects will be randomized to ramelteon or placebo in a double-blind manner as add-on to current treatment. Any other psychotropic medications that the subject is taking at the initiation of participation in this protocol should be continued unchanged throughout the course of this study, except in instances in which these medications require dose reduction for management of side effects. Efficacy and safety assessments will be performed weekly, and the presence of treatment-emergent adverse events will be monitored and recorded.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
The Lindner Center of HOPE | Recruiting |
Mason, Ohio, United States, 45040 | |
Contact: Brian Martens, MS, LSW 513-536-0700 brian.martens@lindnercenter.org | |
Contact: Susan L McElroy, MD 513-536-0700 susan.mcelroy@uc.edu | |
Principal Investigator: Susan L McElroy, MD |
Principal Investigator: | Susan L McElroy, MD | The Lindner Center of HOPE |
Responsible Party: | The Lindner Center of HOPE ( Susan McElroy, MD ) |
Study ID Numbers: | 07-11-06-04 |
Study First Received: | December 20, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00585208 |
Health Authority: | United States: Institutional Review Board |
insomnia sleep disturbance bipolar disorder |
Signs and Symptoms Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Neurologic Manifestations Dyssomnias Sleep Disorders Psychotic Disorders |
Pathologic Processes Disease Nervous System Diseases |