{"protocolSection":{"identificationModule":{"nctId":"NCT01545843","orgStudyIdInfo":{"id":"R01MH077690","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH077690"},"organization":{"fullName":"University of Michigan","class":"OTHER"},"briefTitle":"Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression","officialTitle":"Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression"},"statusModule":{"statusVerifiedDate":"2023-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-03"},"primaryCompletionDateStruct":{"date":"2012-12","type":"ACTUAL"},"completionDateStruct":{"date":"2012-12","type":"ACTUAL"},"studyFirstSubmitDate":"2012-01-12","studyFirstSubmitQcDate":"2012-03-01","studyFirstPostDateStruct":{"date":"2012-03-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-01-13","resultsFirstSubmitQcDate":"2015-01-19","resultsFirstPostDateStruct":{"date":"2015-01-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2023-01-25","lastUpdatePostDateStruct":{"date":"2023-01-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"J. Todd Arnedt","investigatorTitle":"Assistant Professor of Psychiatry","investigatorAffiliation":"University of Michigan"},"leadSponsor":{"name":"University of Michigan","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.","detailedDescription":"Depression is common and associated with social and economic costs. Although antidepressant medications are an effective treatment for depression, it can take as long as 6-8 weeks before symptoms improve, and 20-35% of individuals who use antidepressants still experience depression symptoms.\n\nNew treatments that accelerate response to antidepressants are important to reduce the burden of depression. The objectives of the proposed study are (1) to evaluate the effects of partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of treatment response.\n\nParticipants who are eligible for the study will be randomly assigned to one of three sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6 hours time in bed, with 2 hour advancement of rise time). Participants will spend a total of 7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period."},"conditionsModule":{"conditions":["Depression"],"keywords":["depression","sleep","treatment"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":68,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"No sleep deprivation","type":"ACTIVE_COMPARATOR","description":"Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks","interventionNames":["Behavioral: Sleep scheduling","Drug: Fluoxetine"]},{"label":"Late bedtime sleep deprivation","type":"EXPERIMENTAL","description":"Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.","interventionNames":["Behavioral: Sleep scheduling","Drug: Fluoxetine"]},{"label":"Early risetime sleep deprivation","type":"EXPERIMENTAL","description":"Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.","interventionNames":["Behavioral: Sleep scheduling","Drug: Fluoxetine"]}],"interventions":[{"type":"BEHAVIORAL","name":"Sleep scheduling","description":"8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime","armGroupLabels":["Early risetime sleep deprivation","Late bedtime sleep deprivation","No sleep deprivation"]},{"type":"DRUG","name":"Fluoxetine","description":"20-40 mg fluoxetine daily for 8 weeks","armGroupLabels":["Early risetime sleep deprivation","Late bedtime sleep deprivation","No sleep deprivation"],"otherNames":["Prozac"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Rating Scale for Depression-17 Item Minus Sleep Items","description":"Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.","timeFrame":"Post-treatment (8 weeks)"}],"secondaryOutcomes":[{"measure":"Quick Inventory of Depressive Symptoms (QIDS)","description":"Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.","timeFrame":"Post-treatment (8 weeks)"},{"measure":"Pittsburgh Sleep Quality Index","description":"Self-report measure of sleep quality. The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.","timeFrame":"Baseline, 2 weeks and 8 weeks post-treatment"},{"measure":"Change in EEG Sleep Measures I: Total Sleep Time","description":"Measurement of EEG activity during sleep using polysomnography: Total Sleep Time is the length of time from sleep onset to final wake up minus any wakefulness during the night. It reflects the total amount of time asleep during the night.","timeFrame":"Baseline, 2 weeks, 8 weeks"},{"measure":"Change in EEG Sleep Measures II (Sleep Efficiency)","description":"Measurement of EEG activity during sleep using polysomnography: Sleep efficiency \\[(total sleep time/time in bed)\\*100\\]","timeFrame":"Baseline, 2 weeks, 8 weeks"},{"measure":"Change in Neuropsychological Functioning: Memory","description":"Change in different aspects of thinking (e.g., memory, attention, executive functioning)","timeFrame":"Baseline, 2 weeks, 8 weeks"},{"measure":"Change in Neurologic Functioning: Reaction Time","description":"Reaction Time is measured using a modified Go/No-go test of inhibitory control","timeFrame":"0, 2, 8 weeks"},{"measure":"Neurological Function (Emotional Perception)","description":"Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT)","timeFrame":"0 weeks, 2 weeks, 8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Between 18 and 65 years old\n* Current major depressive episode\n* Habitual TIB of 7 to \\< 10 hours\n* No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting antidepressants)\n* Score of at least 18 on the Hamilton Rating Scale of Depression\n\nExclusion Criteria:\n\n* Alcohol or substance abuse/dependence in past 6 months\n* Current posttraumatic stress disorder or bulimia nervosa (past 6 months)\n* Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder, and anorexia nervosa\n* Trials of fluoxetine in the past 6 months\n* Medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or Cushing's disease); history of head trauma with loss of consciousness of \\> 5 minutes; history of seizures\n* Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder\n* Current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., Sam-E, St. John's Wort)\n* Currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the PI).\n* Currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment.\n* Known allergy, hypersensitivity or contraindication to study medication\n* Females: pregnant or nursing","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"J. Todd Arnedt, Ph.D.","affiliation":"University of Michigan","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","zip":"48109","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}}]},"referencesModule":{"references":[{"pmid":"27529765","type":"DERIVED","citation":"Arnedt JT, Swanson LM, Dopp RR, Bertram HS, Mooney AJ, Huntley ED, Hoffmann RF, Armitage R. Effects of Restricted Time in Bed on Antidepressant Treatment Response: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1218-e1225. doi: 10.4088/JCP.15m09879."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"No Sleep Deprivation","description":"8 hours time in bed for two weeks plus fluoxetine for 8 weeks"},{"id":"FG001","title":"Late Bedtime Sleep Deprivation","description":"6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours."},{"id":"FG002","title":"Early Risetime Sleep Deprivation","description":"6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Rise time advanced by 2 hours."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"25"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"No Sleep Deprivation","description":"8 hours time in bed plus medication\n\nSleep scheduling: 8 hours time in bed for two weeks\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"BG001","title":"Late Bedtime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling:6 hours time in bed for two weeks; bedtime delayed by 2 hours\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"BG002","title":"Early Risetime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling:6 hours time in bed for two weeks; risetime advanced by 2 hours\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"68"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"26.4","spread":"7.4"},{"groupId":"BG001","value":"24.4","spread":"5.6"},{"groupId":"BG002","value":"25.7","spread":"7.0"},{"groupId":"BG003","value":"25.4","spread":"6.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"34"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Rating Scale for Depression-17 Item Minus Sleep Items","description":"Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Post-treatment (8 weeks)","groups":[{"id":"OG000","title":"No Sleep Deprivation","description":"8 hours time in bed plus medication\n\nSleep scheduling: 8 hours time in bed for 2 weeks\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG001","title":"Late Bedtime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG002","title":"Early Risetime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.1","spread":"6.7"},{"groupId":"OG001","value":"8.1","spread":"4.4"},{"groupId":"OG002","value":"6.3","spread":"4.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":".202","statisticalMethod":"Mixed Models Analysis","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Quick Inventory of Depressive Symptoms (QIDS)","description":"Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Post-treatment (8 weeks)","groups":[{"id":"OG000","title":"No Sleep Deprivation","description":"8 hours time in bed plus medication\n\nSleep scheduling: 8 hours vs. 6 hours time in bed for two weeks\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG001","title":"Late Bedtime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG002","title":"Early Risetime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.3","spread":"4.7"},{"groupId":"OG001","value":"6.9","spread":"3.3"},{"groupId":"OG002","value":"6.7","spread":"4.5"}]}]}]},{"type":"SECONDARY","title":"Pittsburgh Sleep Quality Index","description":"Self-report measure of sleep quality. The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.","populationDescription":"At some time points, some participants did not show up to appointments or allow a particular test to be employed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 2 weeks and 8 weeks post-treatment","groups":[{"id":"OG000","title":"No Sleep Deprivation","description":"8 hours time in bed plus medication\n\nSleep scheduling: 8 hours vs. 6 hours time in bed for two weeks\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG001","title":"Late Bedtime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG002","title":"Early Risetime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"15"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"13"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.00","spread":"2.828"},{"groupId":"OG001","value":"8.67","spread":"2.839"},{"groupId":"OG002","value":"6.85","spread":"3.236"}]}]},{"title":"Week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.23","spread":"2.204"},{"groupId":"OG001","value":"6.07","spread":"2.615"},{"groupId":"OG002","value":"5.50","spread":"2.312"}]}]},{"title":"Week 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.86","spread":"2.248"},{"groupId":"OG001","value":"6.23","spread":"2.713"},{"groupId":"OG002","value":"6.33","spread":"2.944"}]}]}]},{"type":"SECONDARY","title":"Change in EEG Sleep Measures I: Total Sleep Time","description":"Measurement of EEG activity during sleep using polysomnography: Total Sleep Time is the length of time from sleep onset to final wake up minus any wakefulness during the night. It reflects the total amount of time asleep during the night.","populationDescription":"Number of participants analyzed decreases in subsequent rows, as some participants dropped out or had unusable data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"minutes","timeFrame":"Baseline, 2 weeks, 8 weeks","groups":[{"id":"OG000","title":"No Sleep Deprivation","description":"8 hours time in bed plus medication\n\nSleep scheduling: 8 hours time in bed for 2 weeks\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG001","title":"Late Bedtime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"},{"id":"OG002","title":"Early Risetime Sleep Deprivation","description":"6 hours time in bed plus medication\n\nSleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime\n\nFluoxetine: 20-40 mg fluoxetine daily for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"25"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"430.132","spread":"60.9230"},{"groupId":"OG001","value":"439.208","spread":"36.3375"},{"groupId":"OG002","value":"444.040","spread":"19.7283"}]}]},{"title":"Week 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"435.382","spread":"25.7206"},{"groupId":"OG001","value":"337.75","spread":"24.69"},{"groupId":"OG002","value":"332.909","spread":"17.0480"}]}]},{"title":"Week 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