Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

NCT00552760 | Completed Phase 4 Results DMC

• 1 other identifier: 07-006R
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) Global Score

  Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0-21, higher scores represent more significant sleep disturbance.

  Monthly for 6 months

Secondary Outcomes (4)

• Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  Monthly for 6 months

• Young Mania Rating Scale (YMRS) Total Score

  Monthly for 6 months

• Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score

  Monthly for 6 months

• Cumulative Proportion of Participants in Each Arm Surviving Without Relapse

  Monthly for 6 months

Study Arms (2)

Ramelteon

EXPERIMENTAL

8 mg

Drug: Ramelteon

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

one 8 mg tablet at bedtime for up to 6 months

Also known as: Rozerem

Ramelteon

Placebo DRUG

one tablet at bedtime for up to 6 months

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent before initiation of any study-related procedures
• Men and women aged 18 to 65 years.
• 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.
• PSQI total score of \>=5.
• MADRS total score of \<=12.
• YMRS total score of \<= 12
• 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.
• Be able to understand and comply with the requirements of the study, as judged by the investigator.
• Outpatient status at enrollment.

You may not qualify if:

• Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.
• Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids.
• Patients with a diagnosis of primary insomnia disorders
• Patients with a diagnosis of severe chronic obstructive pulmonary disease
• 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.
• Patients with active substance abuse diagnoses (except tobacco abuse).
• Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet.

Sponsors & Collaborators

• Lehigh Valley Hospital: lead
• Takeda: collaborator

Study Sites (1)

Lehigh Valley Hospital, Department of Psychiatry

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (6)

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Dokucu ME, Yu L, Taghert PH. Lithium- and valproate-induced alterations in circadian locomotor behavior in Drosophila. Neuropsychopharmacology. 2005 Dec;30(12):2216-24. doi: 10.1038/sj.npp.1300764.

  PMID: 15956996 BACKGROUND

• Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.

  PMID: 444788 BACKGROUND

• Jones SH, Hare DJ, Evershed K. Actigraphic assessment of circadian activity and sleep patterns in bipolar disorder. Bipolar Disord. 2005 Apr;7(2):176-86. doi: 10.1111/j.1399-5618.2005.00187.x.

  PMID: 15762859 BACKGROUND

• American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, CD, American Psychiatric Association, 2000.

  BACKGROUND

• Norris ER, Karen Burke, Correll JR, Zemanek KJ, Lerman J, Primelo RA, Kaufmann MW. A double-blind, randomized, placebo-controlled trial of adjunctive ramelteon for the treatment of insomnia and mood stability in patients with euthymic bipolar disorder. J Affect Disord. 2013 Jan 10;144(1-2):141-7. doi: 10.1016/j.jad.2012.06.023. Epub 2012 Sep 7.

  PMID: 22963894 RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Edward R. Norris, MD
• Organization: Lehigh Valley Hospital

Edward.Norris@lvh.com

(610) 402-5766

Study Officials

• Edward R. Norris, MD

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-Investigator

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 2, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 14, 2014
• Results First Posted: July 5, 2010

Record last verified: 2014-03

Locations

US (1)