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A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression

RecruitingNAAges 18 Years - 65 YearsAllMental Health Centre Copenhagen, Bispebjerg and F…
NCT06005103 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). The participants will use an active or placebo MHB for 30 minutes daily for 8 weeks. Additionally, the following research questions will be answered: 1\. 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. 1\. If the T-PEMF treatment provides improvement in restorative sleep after 8 weeks of treatment

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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). * Female participants: Females in the fertile age must deliver a negative pregnancy test, or previously have been sterilized. * Female fertile participants: They must use safe contraceptive methods to be included in the study, and during the whole study. * Has given written, informed consent to the trial. Exclusion Criteria: * Inability to speak or understand the Danish language. * A current high risk of suicide (a score of 2 or more on the HAM-D-17 item 3). * A co-morbid substance dependence. * Bipolar affective disorder. * Psychotic illness. * Dementia. * Other diagnoses of organic brain disease. * The participant has any kind of implant, e.g. pacemakers or cochlear implants. * Female participants: Pregnancy
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What it tests

  • Treatment with MoodHeadBand (T-PEMF treatment)
  • Inactive treatment with MoodHeadBand (Placebo)
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Where

1 site
Psychiatric Center Copenhagen
Frederiksberg, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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