[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-depressive-disorder-current-episode-severe-without-psychotic-symptoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-depressive-disorder-current-episode-severe-without-psychotic-symptoms":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100516483","a-randomized-clinical-trial-comparing-active-versus-sham-t-pemf-headband-treatment-for-depression-100516483",false,"NCT06005103","A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression","Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial","Inclusion Criteria:\n\n* Meeting the diagnostic criteria for moderate to severe depressive episode without psychotic symptoms according to the International Classification of Diseases and Related Health Problems 10th Revision (ICD-10)(The ICD-10 Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research 1993).\n* Female participants: Females in the fertile age must deliver a negative pregnancy test, or previously have been sterilized.\n* Female fertile participants: They must use safe contraceptive methods to be included in the study, and during the whole study.\n* Has given written, informed consent to the trial.\n\nExclusion Criteria:\n\n* Inability to speak or understand the Danish language.\n* A current high risk of suicide (a score of 2 or more on the HAM-D-17 item 3).\n* A co-morbid substance dependence.\n* Bipolar affective disorder.\n* Psychotic illness.\n* Dementia.\n* Other diagnoses of organic brain disease.\n* The participant has any kind of implant, e.g. pacemakers or cochlear implants.\n* Female participants: Pregnancy","ALL","18 Years","65 Years",{"count":20,"type":21},117,"ESTIMATED","INTERVENTIONAL",[24],"NA","An 8-week, two-armed, randomized-controlled trial that examines the antidepressant effect of treatment with transcranial pulsed electromagnetic fields (T-PEMF) in patients diagnosed with moderate to severe depression using using a new device, the MoodHeadBand (MHB).\n\nThe participants will use an active or placebo MHB for 30 minutes daily for 8 weeks.\n\nAdditionally, the following research questions will be answered:\n\n1\\. If there is a positive effect on the patients' emotional and non-emotional cognition after 8 weeks of active treatment compared to the sham group and if possible early changes in the emotional cognition can predict the treatment response after 8 weeks of treatment.\n\n1\\. If the T-PEMF treatment provides improvement in restorative sleep after 8 weeks of treatment",[27,28,29,30],"Moderate Depression","Severe Depressive Episode Without Psychotic Symptoms","Recurrent Depressive Disorder, Current Episode Moderate","Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms",[32,33,34,35,36,37],"Randomized Controlled Trial","Depression","Transcranial Pulsed Electro-Magnetic Fields (T-PEMF)","Psychiatry","Cognition","Sleep","RECRUITING","2025-08-19",{"date":41,"type":42},"2025-08-26","ACTUAL",{"date":44,"type":42},"2024-06-17",{"date":46,"type":21},"2026-08-30",{"name":48,"class":49},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","OTHER"]