{"protocolSection":{"identificationModule":{"nctId":"NCT00581009","orgStudyIdInfo":{"id":"20011616"},"organization":{"fullName":"University of California, Irvine","class":"OTHER"},"briefTitle":"The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients","officialTitle":"The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients"},"statusModule":{"statusVerifiedDate":"2024-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2001-05-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2011-12-09","type":"ACTUAL"},"completionDateStruct":{"date":"2011-12-09","type":"ACTUAL"},"studyFirstSubmitDate":"2007-12-19","studyFirstSubmitQcDate":"2007-12-26","studyFirstPostDateStruct":{"date":"2007-12-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2024-09-12","resultsFirstSubmitQcDate":"2024-10-14","resultsFirstPostDateStruct":{"date":"2024-10-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-10-14","lastUpdatePostDateStruct":{"date":"2024-10-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Joseph Wu","investigatorTitle":"Professor of Psychiatry & Human Behavior","investigatorAffiliation":"University of California, Irvine"},"leadSponsor":{"name":"University of California, Irvine","class":"OTHER"},"collaborators":[{"name":"University of California, San Diego","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit."},"conditionsModule":{"conditions":["Major Depressive Disorder","Bipolar Disorder"],"keywords":["Sleep deprivation","antidepressant","depression","chronobiological"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1","PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":49,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Chronobiological augmentation","type":"EXPERIMENTAL","description":"chronobiological augmentation group","interventionNames":["Other: chronobiological augmentation"]},{"label":"Medication only","type":"EXPERIMENTAL","description":"medication only group","interventionNames":["Drug: sertraline, lithium"]},{"label":"MDD Mechanism","type":"EXPERIMENTAL","interventionNames":["Radiation: one night of sleep deprivation and two FDG PET scans"]}],"interventions":[{"type":"OTHER","name":"chronobiological augmentation","description":"Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days","armGroupLabels":["Chronobiological augmentation"]},{"type":"DRUG","name":"sertraline, lithium","description":"Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.\n\nMood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks.","armGroupLabels":["Medication only"],"otherNames":["Zoloft","Lithium"]},{"type":"RADIATION","name":"one night of sleep deprivation and two FDG PET scans","description":"MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.","armGroupLabels":["MDD Mechanism"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version","description":"Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.","timeFrame":"within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nInclusion criteria include:\n\n1. Subjects must be English speaking\n2. Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.\n3. Subjects must be between : 18 to 75\n\nNon-English speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than English.\n\nExclusion Criteria:\n\nExclusion criteria include:\n\n1. Suicidality, or psychosis\n2. Unstable medical conditions\n3. Epilepsy, serious head injury, or other significant neurological disorders\n4. Dementia, mental retardation (moderate or severe), coma\n5. Prior exposure to radiation which might cause the subject to exceed standard guidelines\n6. Substance abuse or alcoholism in the past six months\n7. Unreliability or inability to adhere to the requirements of the study\n8. Irregular sleep-wake schedules (nightshift, jet lag)\n9. Use of CNS medications which may affect sleep or functional brain imaging (i.e., use of sleeping pills, antidepressants or other mood stabilizers or other medications which may affect the sleep EEG)\n10. Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders\n11. Donation or loss of blood (\\>400 ml) within the past month\n12. Current or very recent intercurrent illnesses, painful conditions or other disorders, which in the judgement of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for the subject.\n13. Hamilton Rating Scale of Depression (HRSD-17 items)\\<17 unless subject is a normal control subject.\n14. Pregnancy or breast feeding\n15. Individuals who would be unable to undergo a magnetic resonance imaging (MRI) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body.\n16. Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.\n17. Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac\n18. Subjects with diagnosis of eating disorder/bulimia","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Barry F Chaitin, M.D.","affiliation":"University of California, Irvine","role":"STUDY_CHAIR"}],"locations":[{"facility":"University of California, Irvine","city":"Irvine","state":"California","zip":"92697","country":"United States","geoPoint":{"lat":33.66946,"lon":-117.82311}},{"facility":"University of California, San Diego","city":"La Jolla","state":"California","zip":"92093 - 0603","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Medication Only Group","description":"medication only group\n\nMedication as usual, which included sertraline, lithium: Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.\n\nMood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks."},{"id":"FG001","title":"Chronobiological Augmentation Group","description":"chronobiological augmentation group\n\nChronobiological augmentation consists of sleep deprivation for one night, partial sleep phase advance for three nights, and light therapy for two hours for three days"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"32"}]},{"type":"Sample Recruitment","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"32"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"32"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All bipolar depressed subjects","groups":[{"id":"BG000","title":"Chronobiological Augmentation","description":"chronobiological augmentation group\n\nchronobiological augmentation: Chronobiological augmentation consists of sleep deprivation for one night, partial sleep phase advance for three nights and ight therapy for two hours for three days"},{"id":"BG001","title":"Medication Only","description":"medication only group\n\nmedication as usual, including: sertraline, lithium: Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.\n\nMood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"49"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"49"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39","spread":"13"},{"groupId":"BG001","value":"40","spread":"14"},{"groupId":"BG002","value":"39.3","spread":"13.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"29"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"49"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Total Score on the Hamilton Rating Score for Depression (HRSD) - 21 Item Version","description":"Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.","populationDescription":"Bipolar disorder subjects","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Total score on a scale","timeFrame":"within the first seven days up to 7 weeks (plus or minus 1 day) after sleep deprivation and chronobiological therapy","groups":[{"id":"OG000","title":"Chronobiological Augmentation","description":"chronobiological augmentation group\n\nchronobiological augmentation: Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days"},{"id":"OG001","title":"Medication Only","description":"medication only group\n\nsertraline, lithium: Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.\n\nMood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"17"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"19","spread":"6.7"},{"groupId":"OG001","value":"18.5","spread":"7.1"}]}]},{"title":"Day 7","categories":[{"measurements":[{"groupId":"OG000","value":"10.2","spread":"7.3"},{"groupId":"OG001","value":"14.4","spread":"8"}]}]},{"title":"Week 7","categories":[{"measurements":[{"groupId":"OG000","value":"10.1","spread":"9.6"},{"groupId":"OG001","value":"15.2","spread":"10.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"repeated measure ANOVA","pValue":"<0.05","statisticalMethod":"ANOVA","paramType":"t-value","paramValue":"3.34","ciNumSides":"TWO_SIDED"}]}]},"adverseEventsModule":{"frequencyThreshold":"4","eventGroups":[{"id":"EG000","title":"Chronobiological Augmentation","description":"chronobiological augmentation group\n\nchronobiological augmentation: Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days","deathsNumAffected":0,"deathsNumAtRisk":32,"seriousNumAffected":0,"seriousNumAtRisk":32,"otherNumAffected":2,"otherNumAtRisk":32},{"id":"EG001","title":"Medication Only","description":"medication only group\n\nsertraline, lithium: Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks.\n\nMood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks.","deathsNumAffected":0,"deathsNumAtRisk":17,"seriousNumAffected":0,"seriousNumAtRisk":17,"otherNumAffected":0,"otherNumAtRisk":17}],"otherEvents":[{"term":"brief hypomanic switch","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"brief hypomanic period including pressured speech and elevated mood","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":17}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Joseph Wu","organization":"University of California Irvine","email":"jcwu@uci.edu","phone":"7142252212"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D001714","term":"Bipolar Disorder"},{"id":"D012892","term":"Sleep Deprivation"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D000068105","term":"Bipolar and Related Disorders"},{"id":"D020920","term":"Dyssomnias"},{"id":"D012893","term":"Sleep Wake Disorders"},{"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"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D020280","term":"Sertraline"},{"id":"D008094","term":"Lithium"}],"ancestors":[{"id":"D015057","term":"1-Naphthylamine"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009281","term":"Naphthalenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D008672","term":"Metals, Alkali"},{"id":"D004602","term":"Elements"},{"id":"D007287","term":"Inorganic Chemicals"},{"id":"D019565","term":"Metals, Light"},{"id":"D008670","term":"Metals"}]}},"hasResults":true}