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
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.
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.
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Lead sponsor
Innovation Fund Denmark
Collaborator
Danish Medical Association
Collaborator
Doctor Gerhard Linds scholarship
Collaborator
MoodHeadBand Aps
Collaborator