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

This study has been terminated.
(sponsor terminated study)
Sponsor:
Collaborators:
Takeda
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00585208
First received: December 20, 2007
Last updated: May 8, 2013
Last verified: May 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

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 ]

Enrollment: 21
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585208

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

Publications:
Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00585208     History of Changes
Other Study ID Numbers: 07-11-06-04
Study First Received: December 20, 2007
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Dyssomnias
Sleep Disorders
Parasomnias
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014