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

Summary

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

Eligibility

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

Conditions5

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