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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585208
Recruitment Status : Terminated (sponsor terminated study)
First Posted : January 3, 2008
Last Update Posted : May 10, 2013
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE

Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia Bipolar Disorder Drug: Ramelteon Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Add-On Ramelteon in Ambulatory Bipolar I Disorder With Clinically Significant Sleep Disturbance
Study Start Date : December 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active drug
Ramelteon - this group receives active drug at a fixed dose of 8mg daily throughout study
Drug: Ramelteon
Ramelteon 8mg daily
Other Name: Rozerem
Placebo Comparator: Placebo (sugar pill)
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

Primary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ]
  2. Pittsburgh Insomnia Rating Scale (PIRS) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Young Mania Rating Scale (YMRS) [ Time Frame: 8 weeks ]
  2. Inventory of Depressive Symptoms (IDS) [ Time Frame: 8 weeks ]
  3. Hamilton Anxiety Scale (HAM-A) [ Time Frame: 8 weeks ]
  4. Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) [ Time Frame: 8 weeks ]
  5. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585208

United States, Ohio
The Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati
Principal Investigator: Susan L McElroy, MD The Lindner Center of HOPE

Publications of Results:
Responsible Party: Lindner Center of HOPE Identifier: NCT00585208     History of Changes
Other Study ID Numbers: 07-11-06-04
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by Lindner Center of HOPE:
sleep disturbance
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms