Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT00552760
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2007-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C495910', 'term': 'ramelteon'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Edward.Norris@lvh.com', 'phone': '(610) 402-5766', 'title': 'Edward R. Norris, MD', 'organization': 'Lehigh Valley Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months', 'otherNumAtRisk': 42, 'otherNumAffected': 12, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months', 'otherNumAtRisk': 41, 'otherNumAffected': 12, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diarrhea NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Forgetfulness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Insomnia exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Restless legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vivid dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pittsburgh Sleep Quality Index (PSQI) Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.17', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '10.88', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '8.16', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '9.28', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '7.93', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '9.71', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '7.89', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '10.38', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '7.21', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '9.03', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '6.62', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '8.66', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '6.90', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '8.76', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for 6 months', 'description': '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.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis; excludes 7 screen failures.'}, {'type': 'SECONDARY', 'title': 'Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.79', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '8.27', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '8.34', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '8.90', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '7.23', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '11.13', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '9.17', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '11.85', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '8.45', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '13.03', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '8.56', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '11.59', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '10.40', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '10.46', 'spread': '2.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for 6 months', 'description': '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.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis; excludes 7 screen failures'}, {'type': 'SECONDARY', 'title': 'Young Mania Rating Scale (YMRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.02', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '6.59', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '5.89', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '5.91', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '7.75', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '6.60', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '8.09', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '5.93', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '4.95', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '5.18', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '6.51', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '6.72', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for 6 months', 'description': '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.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis; excludes 7 screen failures'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.29', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.24', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.53', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '2.36', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '2.46', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '2.54', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for 6 months', 'description': '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.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis; excludes 7 screen failures'}, {'type': 'SECONDARY', 'title': 'Cumulative Proportion of Participants in Each Arm Surviving Without Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000'}, {'value': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '0.929', 'groupId': 'OG000'}, {'value': '0.951', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '0.849', 'groupId': 'OG000'}, {'value': '0.588', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.716', 'groupId': 'OG000'}, {'value': '0.448', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '0.661', 'groupId': 'OG000'}, {'value': '0.384', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '0.632', 'groupId': 'OG000'}, {'value': '0.320', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.566', 'groupId': 'OG000'}, {'value': '0.320', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Monthly for 6 months', 'description': '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.', 'unitOfMeasure': 'Cumulative proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis; excludes 7 screen failures.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Relapsed- Depressed Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Relapse- Manic Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Relapsed- Mixed Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Medical Condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Medication Change', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ramelteon', 'description': 'one 8 mg tablet at bedtime for up to 6 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'one tablet at bedtime for up to 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '45.9', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2007-10-31', 'resultsFirstSubmitDate': '2010-05-29', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-01', 'studyFirstPostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index (PSQI) Global Score', 'timeFrame': 'Monthly for 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Monthly for 6 months', 'description': '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.'}, {'measure': 'Young Mania Rating Scale (YMRS) Total Score', 'timeFrame': 'Monthly for 6 months', 'description': '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.'}, {'measure': 'Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score', 'timeFrame': 'Monthly for 6 months', 'description': '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.'}, {'measure': 'Cumulative Proportion of Participants in Each Arm Surviving Without Relapse', 'timeFrame': 'Monthly for 6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '2748771', 'type': 'BACKGROUND', 'citation': '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': '15956996', 'type': 'BACKGROUND', 'citation': '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': '444788', 'type': 'BACKGROUND', 'citation': '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': '15762859', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, CD, American Psychiatric Association, 2000.'}, {'pmid': '22963894', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.', 'detailedDescription': "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.\n\nPatients 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of written informed consent before initiation of any study-related procedures\n2. Men and women aged 18 to 65 years.\n3. 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.\n4. PSQI total score of \\>=5.\n5. MADRS total score of \\<=12.\n6. YMRS total score of \\<= 12\n7. 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.\n8. Be able to understand and comply with the requirements of the study, as judged by the investigator.\n9. Outpatient status at enrollment.\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.\n2. Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids.\n3. Patients with a diagnosis of primary insomnia disorders\n4. Patients with a diagnosis of severe chronic obstructive pulmonary disease\n5. 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.\n6. Patients with active substance abuse diagnoses (except tobacco abuse).\n7. Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet."}, 'identificationModule': {'nctId': 'NCT00552760', 'acronym': 'Ram-TIME', 'briefTitle': 'Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Lehigh Valley Hospital'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Trial of Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder.', 'orgStudyIdInfo': {'id': '07-006R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ramelteon', 'description': '8 mg', 'interventionNames': ['Drug: Ramelteon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ramelteon', 'type': 'DRUG', 'otherNames': ['Rozerem'], 'description': 'one 8 mg tablet at bedtime for up to 6 months', 'armGroupLabels': ['Ramelteon']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'one tablet at bedtime for up to 6 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital, Department of Psychiatry', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}], 'overallOfficials': [{'name': 'Edward R. Norris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Valley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lehigh Valley Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-Investigator', 'investigatorFullName': 'Edward R. Norris, MD', 'investigatorAffiliation': 'Lehigh Valley Hospital'}}}}