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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon | Experimental | 8 mg |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | one 8 mg tablet at bedtime for up to 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 10-item, standardized, well-validated scale used to measure severity of depressive symptoms; sensitive to treatment effects in depressed outpatients. Scores range from 0-60, higher scores represent more severe depressive symptoms. | Monthly for 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward R. Norris, MD | Lehigh Valley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Valley Hospital, Department of Psychiatry | Allentown | Pennsylvania | 18103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2748771 | Background | 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. | |
| 15956996 | 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. |
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90 participants signed the informed consent document, 7 were screen failures, and 83 were randomized to receive either Ramelteon or placebo. During the study, both groups were maintained on their usual medications for bipolar disorder and were not allowed to have any meds changed, as this would signify a manic or depressed event.
Recruitment began in October 2007 and was completed by August 2009. Participants, who at the time were receiving outpatient psychiatric services through Lehigh Valley Hospital, were recruited via referral through the department of psychiatry, and also through print advertisement. Participants received a $20 travel stipend for each appointment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon | one 8 mg tablet at bedtime for up to 6 months |
| FG001 | Placebo | one tablet at bedtime for up to 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon | one 8 mg tablet at bedtime for up to 6 months |
| BG001 | Placebo | one tablet at bedtime for up to 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Treat Analysis; excludes 7 screen failures. | Posted | Mean | Standard Error | units on scale | Monthly for 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon | one 8 mg tablet at bedtime for up to 6 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward R. Norris, MD | Lehigh Valley Hospital | (610) 402-5766 | Edward.Norris@lvh.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| Placebo | Drug | one tablet at bedtime for up to 6 months |
|
| Young Mania Rating Scale (YMRS) Total Score |
11-item standardized, well-validated scale used to measure manic symptoms; sensitive to treatment effects in manic patients. Scores range from 0-60, higher scores represent more severe manic symptoms. |
| Monthly for 6 months |
| Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score | 3-part (mania, depression, overall bipolar illness), physician-administered scale used to assess global illness severity; used to measure change. Each part is rated from 1-7, higher scores represent more severe mental illness. Only overall bipolar rating was used. | Monthly for 6 months |
| Cumulative Proportion of Participants in Each Arm Surviving Without Relapse | Survival analysis techniques, including Kaplan Meier curves, were used to evaluate group differences in time to relapse. Relapse was defined as a medication initiation or change for manic/depressed/mixed symptoms, a hospitalization for manic/depressed/mixed symptoms, MADRS score >= 16, YMRS score > 14, and suicide risk or imminent risk of suicide. Time to relapse was measured discretely in terms of the number of assessment visits until discontinued from the study. | Monthly for 6 months |
| 444788 | 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. |
| 15762859 | 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. |
| Background | American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, CD, American Psychiatric Association, 2000. |
| 22963894 | Result | 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. |
| Relapse- Manic Event |
|
| Relapsed- Mixed Event |
|
| Protocol Violation |
|
| Lost to Follow-up |
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| Non-compliance |
|
| Medical Condition |
|
| Withdrawal by Subject |
|
| Medication Change |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 10-item, standardized, well-validated scale used to measure severity of depressive symptoms; sensitive to treatment effects in depressed outpatients. Scores range from 0-60, higher scores represent more severe depressive symptoms. | Intent to Treat Analysis; excludes 7 screen failures | Posted | Mean | Standard Error | units on scale | Monthly for 6 months |
|
|
|
| Secondary | Young Mania Rating Scale (YMRS) Total Score | 11-item standardized, well-validated scale used to measure manic symptoms; sensitive to treatment effects in manic patients. Scores range from 0-60, higher scores represent more severe manic symptoms. | Intent to Treat Analysis; excludes 7 screen failures | Posted | Mean | Standard Error | units on scale | Monthly for 6 months |
|
|
|
| Secondary | Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score | 3-part (mania, depression, overall bipolar illness), physician-administered scale used to assess global illness severity; used to measure change. Each part is rated from 1-7, higher scores represent more severe mental illness. Only overall bipolar rating was used. | Intent to Treat Analysis; excludes 7 screen failures | Posted | Mean | Standard Error | units on scale | Monthly for 6 months |
|
|
|
| Secondary | Cumulative Proportion of Participants in Each Arm Surviving Without Relapse | Survival analysis techniques, including Kaplan Meier curves, were used to evaluate group differences in time to relapse. Relapse was defined as a medication initiation or change for manic/depressed/mixed symptoms, a hospitalization for manic/depressed/mixed symptoms, MADRS score >= 16, YMRS score > 14, and suicide risk or imminent risk of suicide. Time to relapse was measured discretely in terms of the number of assessment visits until discontinued from the study. | Intent to Treat Analysis; excludes 7 screen failures. | Posted | Number | Cumulative proportion of participants | Monthly for 6 months |
|
|
|
| 0 |
| 42 |
| 12 |
| 42 |
| EG001 | Placebo | one tablet at bedtime for up to 6 months | 0 | 41 | 12 | 41 |
| Diarrhea NOS | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dizziness | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dry mouth | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Forgetfulness | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Headache NOS | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Insomnia exacerbated | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Restless legs | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Somnolence | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vivid dreams | General disorders | MedDRA (11.1) | Systematic Assessment |
|
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