[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516483":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":46,"responsibleParty":67,"collaborators":70,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":25,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"(A) Patients diagnosed with moderate to severe depression without psychotic symptoms","EXPERIMENTAL","In total, 48 patients will be allocated to this arm.\n\n(In total, 117 patients will be included in the study. Data for the initial 21 patients included in the study could not be used to assess the antidepressant effect, why an increased number of participants was needed to secure the power for the trial. The technical difficulties have been addressed)",[13],"Device: Treatment with MoodHeadBand (T-PEMF treatment)",{"label":15,"type":16,"description":11,"interventionNames":17},"(B) Patients diagnosed with moderate to severe depression without psychotic symptoms","SHAM_COMPARATOR",[18],"Device: Inactive treatment with MoodHeadBand (Placebo)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Treatment with MoodHeadBand (T-PEMF treatment)","The patients will receive treatment with T-PEMF using a headband containing 20 coils placed symmetrically around the head of the patient. The device delivers 55 Hz magnetic field. Duration of treatment is 30 minutes once a day for 8 weeks.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Inactive treatment with MoodHeadBand (Placebo)","Patients will use an identical device, which does not deliver T-PEMF treatment. The patients will use the headband as the active group for 30 minutes, once a day, for 8 weeks.",[15],[31],{"name":32,"affiliation":33,"role":34},"Martin B. Jørgensen, MD MSc","Psychiatric Center Copenhagen","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Martin B. Jørgensen, MD DMSc","CONTACT","23328669","+45","Martin.Balslev.Joergensen@regionh.dk",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Nana B Sørensen, MD","26356751","nana.brandborg.soerensen@regionh.dk",[47],{"facility":33,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Frederiksberg","Capital Region","2600","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],12.53463,55.67938,{"lat":58,"lon":57},[61,64],{"name":62,"role":38,"phone":63,"phoneExt":40,"email":45},"Nana B. Sørensen, MD","23 26 70 81",{"name":65,"role":66,"phone":25,"phoneExt":25,"email":25},"Nana Brandborg B. Sørensen, MD","SUB_INVESTIGATOR",{"type":34,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Martin Balslev Jørgensen","Professor, dr. med.",[71,74,76,79],{"name":72,"class":73},"Innovation Fund Denmark","INDIV",{"name":75,"class":6},"Danish Medical Association",{"name":77,"class":78},"Doctor Gerhard Linds scholarship","UNKNOWN",{"name":80,"class":78},"MoodHeadBand Aps","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":92,"type":93},117,"ESTIMATED","INTERVENTIONAL",[96],"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",[99,100,101,102],"Moderate Depression","Severe Depressive Episode Without Psychotic Symptoms","Recurrent Depressive Disorder, Current Episode Moderate","Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms",[104,105,106,107,108,109],"Randomized Controlled Trial","Depression","Transcranial Pulsed Electro-Magnetic Fields (T-PEMF)","Psychiatry","Cognition","Sleep","2025-08-19",{"date":112,"type":113},"2025-08-26","ACTUAL",{"date":115,"type":113},"2024-06-17",{"date":117,"type":93},"2026-08-30",{"name":5,"class":6},1]