[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544627":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":72,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":32,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":32,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":57,"whyStopped":32,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Jagiellonian University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"iTBS over the left DLPFC","ACTIVE_COMPARATOR","Active iTBS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 magnetic pulses will be elicited.",[13],"Device: iTBS",{"label":15,"type":16,"description":17,"interventionNames":18},"cTBS over the right DLPFC","EXPERIMENTAL","Active cTBS with intensity of 120% of the resting motor threshold recorded from the left first dorsal interosseus will be administered over the right DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 1200 magnetic pulses will be elicited.",[19],"Device: cTBS",{"label":21,"type":22,"description":23,"interventionNames":24},"Sham stimulation","SHAM_COMPARATOR","Active iTBS or cTBS will be administered over the left or right DLPFC respectively with sham coil. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 or 1200 magnetic pulses will be elicited.",[25],"Device: Sham",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","iTBS","Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"cTBS","Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.",[15],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Sham","Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.",[21],[42],{"name":43,"affiliation":44,"role":45},"Bogdan Stefanowski, MD","Institute of Psychiatry and Neurology","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":32,"email":50},"CONTACT","+48 22 45 82 532","bstefanowski@ipin.edu.pl",{"name":52,"role":48,"phone":53,"phoneExt":32,"email":54},"Jakub Antczak, MD","+48 12 400 25 50","jakub.antczak@uj.edu.pl",[56],{"facility":44,"status":57,"city":58,"state":32,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Warsaw","02957","Poland","PL",{"type":63,"coordinates":64},"Point",[65,66],21.01178,52.22977,{"lat":66,"lon":65},[69,71],{"name":70,"role":48,"phone":49,"phoneExt":32,"email":50},"Bogdan Stefanowski",{"name":52,"role":48,"phone":53,"phoneExt":32,"email":54},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Jakub Antczak","Clinical Professor",[77],{"name":78,"class":6},"Institute of Psychiatry and Neurology, Warsaw","100544627","effect-of-intermittent-and-continuous-theta-burst-stimulation-on-sleep-daytime-sleepiness-and-fatigue-in-depression-100544627",false,"NCT06371352","Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression","Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression","Inclusion Criteria:\n\n* severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion\n* Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4).\n* The score of the Athens Insomnia Scale five or more\n* Unchanged antidepressive pharmacotherapy at least one month prior to inclusion\n\nExclusion Criteria:\n\n* Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy\n* Psychotic symptoms at the time of inclusion\n* Suicidal ideations and\u002For attempts within three months prior to inclusion","ALL","18 Years","65 Years",{"count":90,"type":91},90,"ESTIMATED","INTERVENTIONAL",[94],"NA","Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.",[97,98],"Unipolar Depression","Bipolar Disorder",[97,98,100,101,102,103,104],"theta burst stimulation","sleep","sleepiness","fatigue","transcranial magnetic stimulation","2024-10-10",{"date":107,"type":108},"2024-10-15","ACTUAL",{"date":110,"type":108},"2024-05-15",{"date":112,"type":91},"2027-05",{"name":74,"class":6},1]