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Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance
This study is currently recruiting participants.
Verified by University of Cincinnati, October 2008
Sponsors and Collaborators: University of Cincinnati
Takeda Global Research & Development Center, Inc.
The Lindner Center of HOPE
Information provided by: University of Cincinnati
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

MedlinePlus related topics: Bipolar Disorder Sleep Disorders
Drug Information available for: Ramelteon
U.S. FDA Resources
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

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Pittsburgh Insomnia Rating Scale (PIRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Inventory of Depressive Symptoms (IDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Scale (HAM-A) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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
1: Active Comparator
Ramelteon
Drug: Ramelteon
fixed dose of 8 mg daily at bedtime throughout the study
2: Placebo Comparator
placebo
Drug: placebo
taken daily at bedtime

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. Subjects must be 18 to 65 years of age, inclusive.
  2. Subjects must have lifetime bipolar I disorder as defined by DSM-IV-TR criteria.
  3. Subjects' manic symptoms must be mild to moderate in severity, defined as an YMRS score between 10 and 25.
  4. Subjects must be currently experiencing a clinically significant sleep disturbance, defined as a PSQI total score > 5.
  5. Subjects must be receiving at least 1 mood stabilizing medication, which may include an atypical antipsychotic (e.g., aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone) and/or mood stabilizer/anticonvulsant (e.g, lithium, carbamazepine, valproate/divalproex, lamotrigine, oxcarbazepine) medication for > 1 week prior to baseline. Continued administration of benzodiazepines or sedative-hypnotics will be allowed only if the subject has been receiving the medication for > 2 weeks prior to baseline.
  6. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
  7. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least 1 month prior to study entry and throughout the study.

Exclusion Criteria:

  1. Subjects who are experiencing clinically significant suicidal or homicidal ideation.
  2. Subjects who are currently experiencing psychotic symptoms.
  3. Subjects with a current DSM-IV-TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV-TR diagnosis of a substance dependence disorder within the past 6 months; or, a lifetime DSM-IV-TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
  4. Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the investigator.
  5. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement for > 3 months.
  6. Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory studies.
  7. Subjects who are allergic to or who have demonstrated hypersensitivity to ramelteon.
  8. Subjects who are taking medications that interact with ramelteon (e.g., ketoconazole, fluconazole, fluvoxamine, rifampin).
  9. Females who are pregnant or nursing.
  10. Subjects who have received an experimental drug or used an experimental device within 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585208

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: Susan L McElroy, MD     513-536-0700     susan.mcelroy@uc.edu    
Principal Investigator: Susan L McElroy, MD            
Sponsors and Collaborators
University of Cincinnati
Takeda Global Research & Development Center, Inc.
The Lindner Center of HOPE
Investigators
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 14, 2008
ClinicalTrials.gov Identifier: NCT00585208  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
insomnia
sleep disturbance
bipolar disorder

Study placed in the following topic categories:
Signs and Symptoms
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Neurologic Manifestations
Dyssomnias
Sleep Disorders
Psychotic Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009