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Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder (Ram-TIME)
This study is ongoing, but not recruiting participants.
First Received: October 31, 2007   Last Updated: September 30, 2009   History of Changes
Sponsor: Lehigh Valley Hospital
Collaborator: Takeda Global Research & Development Center, Inc.
Information provided by: Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00552760
  Purpose

The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.


Condition Intervention
Bipolar Disorder
 Drug: Ramelteon
Drug: placebo

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Double-blind, Randomized, Placebo Controlled Trial of Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder.

Resource links provided by NLM:

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

Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • The primary variable measured will be the change from randomization in Pittsburgh Sleep Quality Index (PSQI) global score. [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the change from randomization in MADRS total score [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]
  • the change from randomization in YMRS total score [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]
  • the mean change from randomization in CGI-BP severity of illness score [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]
  • the occurrence of a manic or depressed event as evidenced by a YMRS score => 14 and/or a MADRS => 16 for 2 consecutive weeks, hospitalization for manic/depressed symptoms, initiation of pharmacologic treatment for manic/depressed symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ramelteon: Experimental
Ramelteon 8 mg P.O. at bedtime
Drug: Ramelteon
Ramelteon 8 mg tablet or Placebo P.O. at bedtime for 6 months
Placebo: Placebo Comparator
Placebo one tablet at bed
Drug: placebo
placebo tablet one P.O. at bedtime

Detailed Description:

Patients with euthymic bipolar disorder, although free of significant mood symptoms, often have continued sleep disturbances. Improving patients' sleep by also normalizing the circadian rhythm will lead to fewer mood exacerbations. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for bipolar patients will improve sleep and will cause fewer mood exacerbations.

Patients with Bipolar disorder often experience frequent mood alterations that are attempted to be controlled by mood stabilizing agents and anti-psychotic agents. Both classes of medications have numerous significant side effects. Establishing that ramelteon is helpful in the sleep of patients with bipolar disorder and helpful in mood stability will increase the number of treatment options for bipolar patients

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent before initiation of any study-related procedures
  2. Men and women aged 18 to 65 years.
  3. A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.4x Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed.
  4. PSQI total score of >=5.
  5. MADRS total score of <=12.
  6. YMRS total score of <= 12
  7. Female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study.
  8. Be able to understand and comply with the requirements of the study, as judged by the investigator.
  9. Outpatient status at enrollment.

Exclusion Criteria:

  1. Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.
  2. Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids.
  3. Patients with a diagnosis of primary insomnia disorders
  4. Patients with a diagnosis of severe chronic obstructive pulmonary disease
  5. A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes, angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
  6. Patients with active substance abuse diagnoses (except tobacco abuse).
  7. Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552760

Locations
United States, Pennsylvania
Lehigh Valley Hospital, Department of Psychiatry
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
Lehigh Valley Hospital
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Edward R. Norris, MD Lehigh Valley Hospital
  More Information

No publications provided

Responsible Party: Lehigh Valley Hospital ( Edward R. Norris, MD )
Study ID Numbers: 07-006R
Study First Received: October 31, 2007
Last Updated: September 30, 2009
ClinicalTrials.gov Identifier: NCT00552760     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Affective Disorders, Psychotic
Pathologic Processes
Disease
 Mental Disorders
Bipolar Disorder
Mood Disorders

ClinicalTrials.gov processed this record on February 09, 2010



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