Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT00631657
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2008-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Belgium', 'Canada', 'Chile', 'France', 'Germany', 'Hungary', 'Italy', 'Mexico', 'Netherlands', 'Poland', 'South Korea', 'Sweden', 'Taiwan', 'Thailand', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078785', 'term': 'Mirtazapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days after last dose of study drug (up to 31 weeks)', 'description': 'AE data include AEs that occurred during the 6-month Treatment Period and the 7-day Discontinuation Period. AEs are reported for the study drug participants were receiving at the time the AE occurred.', 'eventGroups': [{'id': 'EG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD', 'otherNumAtRisk': 342, 'otherNumAffected': 183, 'seriousNumAtRisk': 342, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD', 'otherNumAtRisk': 115, 'otherNumAffected': 40, 'seriousNumAtRisk': 115, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 42, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 63, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 56, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sudden visual loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Synovial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bunion operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '71.9', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '62.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.7', 'ciLowerLimit': '35.0', 'ciUpperLimit': '62.5', 'estimateComment': 'ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline TST as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'TST was defined as the time recorded for sleep diary question 6 "How much time did you actually spend sleeping?" as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline TST efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD'}], 'classes': [{'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 31 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 27 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The AST population consisted of all participants who received at least one dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.7', 'spread': '47.3', 'groupId': 'OG000'}, {'value': '-26.9', 'spread': '46.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '2.8', 'estimateComment': 'ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline SL as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'SL was defined as the time recorded for sleep diary question 3 "How long did it take you to fall asllep?", as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline SL efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.4', 'spread': '57.7', 'groupId': 'OG000'}, {'value': '-20.8', 'spread': '51.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.0', 'ciLowerLimit': '-34.5', 'ciUpperLimit': '-15.4', 'estimateComment': 'ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline WASO as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'WASO was defined as the time recorded for sleep diary question 5 "How much time were you awake, after falling asleep initially?", as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline WASO efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'NAW was defined as the number of times recorded for sleep diary question 4a "How many times did you wake up during the night?", as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline NAW efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Sleep Quality - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 "Rate the quality of your sleep last night", as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Sleep Quality efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '15.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 "How satisfied are you about your sleep duration of last night?", as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Satisfaction with Sleep Duration efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}], 'classes': [{'title': 'Change from BL at Week 26 - PCS', 'categories': [{'measurements': [{'value': '1.6', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from BL at Week 26 - MCS', 'categories': [{'measurements': [{'value': '4.6', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 SF-36 efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 IGR efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Investigator Global Rating (IGR) - 7-Day Discontinuation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by esmirtazapine 4.5 mg tablets, administered QD for 7 days during the Discontinuation Period'}, {'id': 'OG001', 'title': 'Esmirtazapine 4.5 mg/Placebo', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period'}, {'id': 'OG002', 'title': 'Placebo/Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of 7-day Discontinuation Period', 'description': 'The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a 7-Day Discontinuation Period IGR efficacy assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered once a day (QD) for 6 months, then participants receive esmirtazapine 4.5 mg tablets, administered QD for 7 days'}, {'id': 'FG001', 'title': 'Esmirtazapine 4.5 mg/Placebo', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days'}, {'id': 'FG002', 'title': 'Placebo/Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days'}], 'periods': [{'title': '6-Month Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'Treated', 'achievements': [{'comment': 'Two randomized participants were not treated during the 6-month Treatment Period.', 'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'One randomized participant was not treated during the 6-month Treatment Period.', 'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Uncooperative Reasons Unrelated to Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': '7-Day Discontinuation Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant was radomized in the Discont. Period, without completing the Treatment Period.', 'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'Treated', 'achievements': [{'comment': 'One participant was not treated during the Discontinuation Period.', 'groupId': 'FG000', 'numSubjects': '66'}, {'comment': 'One participant was not treated during the Discontinuation Period.', 'groupId': 'FG001', 'numSubjects': '136'}, {'comment': 'One participant was not treated during the Discontinuation Period.', 'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receive placebo tablets, administered QD for 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '49.0', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '47.8', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Baseline Analysis Population consists of all participants who received study drug. Two participants in the esmertazapine 4.5 mg group and one participant in the placebo group did not receive study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'dispFirstSubmitDate': '2009-12-03', 'completionDateStruct': {'date': '2009-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2008-02-29', 'dispFirstSubmitQcDate': '2009-12-03', 'resultsFirstSubmitDate': '2014-05-15', 'studyFirstSubmitQcDate': '2008-02-29', 'dispFirstPostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-03', 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'NAW was defined as the number of times recorded for sleep diary question 4a "How many times did you wake up during the night?", as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.'}, {'measure': 'Change From Baseline in Sleep Quality - 6-Month Treatment Period', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 "Rate the quality of your sleep last night", as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.'}, {'measure': 'Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 "How satisfied are you about your sleep duration of last night?", as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.'}, {'measure': 'Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period', 'timeFrame': 'Baseline and Week 26', 'description': 'SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization.'}, {'measure': 'Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period', 'timeFrame': 'Baseline and Week 26', 'description': 'The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment.'}, {'measure': 'Change From Baseline in Investigator Global Rating (IGR) - 7-Day Discontinuation Period', 'timeFrame': 'Baseline and End of 7-day Discontinuation Period', 'description': 'The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'TST was defined as the time recorded for sleep diary question 6 "How much time did you actually spend sleeping?" as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced Adverse Events (AEs)', 'timeFrame': 'Up to 31 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'timeFrame': 'Up to 27 weeks', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.'}, {'measure': 'Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'SL was defined as the time recorded for sleep diary question 3 "How long did it take you to fall asllep?", as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.'}, {'measure': 'Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period', 'timeFrame': 'Baseline and the Mean of Weeks 14-26', 'description': 'WASO was defined as the time recorded for sleep diary question 5 "How much time were you awake, after falling asleep initially?", as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['placebo controlled', 'randomized', 'double blind'], 'conditions': ['Sleep Initiation and Maintenance Disorders', 'Mental Disorders', 'Dyssomnias', 'Sleep Disorders', 'Sleep Disorder, Intrinsic']}, 'referencesModule': {'references': [{'pmid': '32351205', 'type': 'DERIVED', 'citation': 'Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).', 'detailedDescription': 'Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.\n\nThe maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on TST (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.\n\nThe current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. During the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. Then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are at least 18 and less than 65 years;\n* sign written informed consent after the scope and nature of the investigation have been explained;\n* have shown capability to complete the LogPad questionnaires;\n* have difficulty falling asleep, maintaining sleep or have early morning awakening;\n\nExclusion Criteria:\n\n* Significant medical or psychiatric illness causing sleep disturbances.\n* Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.\n* Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.\n* Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.\n* Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.\n* Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.\n* Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.\n* Routinely nap during the day.\n* Have a Body Mass Index (BMI) of 36 or more.'}, 'identificationModule': {'nctId': 'NCT00631657', 'briefTitle': 'A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Outpatient Trial, Investigating the Efficacy and Safety of Org 50081 in Adult Patients With Chronic Primary Insomnia', 'orgStudyIdInfo': {'id': 'P05701'}, 'secondaryIdInfos': [{'id': '21106', 'type': 'OTHER', 'domain': 'Organon Protocol Number'}, {'id': '2007-005236-92', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esmirtazapine 4.5 mg', 'description': 'Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months', 'interventionNames': ['Drug: Esmirtazapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive placebo tablets, administered once a day for 6 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Esmirtazapine', 'type': 'DRUG', 'description': 'One esmirtazapine 4.5 mg tablet once a day', 'armGroupLabels': ['Esmirtazapine 4.5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One placebo tablet once a day', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}