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| Sponsor: | Lindner Center of HOPE |
|---|---|
| Collaborators: |
Takeda Global Research & Development Center, Inc. University of Cincinnati |
| Information provided by: | Lindner Center of HOPE |
| ClinicalTrials.gov Identifier: | NCT00585208 |
Purpose
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 |
|---|---|---|
|
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: | February 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active drug: Active Comparator
Ramelteon - this group receives active drug at a fixed dose of 8mg daily throughout study
|
Drug: Ramelteon
Ramelteon 8mg daily
|
|
Placebo (sugar pill): Placebo Comparator
placebo (sugar pill) - this arm receive the fake pill, also know as placebo or the sugar pill
|
Drug: Placebo
matching placebo for ramelteon 8mg daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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: Dianna Moeller, BA 513-536-0707 dianna.moeller@lindnercenter.org | |
| Principal Investigator: Susan L McElroy, MD | |
| Principal Investigator: | Susan L McElroy, MD | The Lindner Center of HOPE |
More Information
| 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 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00585208 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
insomnia sleep disturbance bipolar disorder |
|
Signs and Symptoms Affective Disorders, Psychotic Pathologic Processes Disease Mental Disorders Bipolar Disorder |
Nervous System Diseases Mood Disorders Neurologic Manifestations Sleep Disorders Dyssomnias |