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.
Parallel
Treatment with MoodHeadBand (T-PEMF treatment)
DeviceThe 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.
Inactive treatment with MoodHeadBand (Placebo)
DevicePatients 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.
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
The IDS-SR is a 30-item self-report scale for measuring depressive symptoms, with satisfying psychometric features and good correlations with Hamilton-D17 (HAM-D17).
Hamilton-D17 (HAM-D17)
A scale measuring depressive symptoms. Will be applied at baseline and at the end point
Hamilton-D6 (HAM-D6)
A scale measuring depressive symptoms. Will be applied at baseline and at the end point.
Quick Inventory of Depressive Symptomatology
A quick-version of the IDS questionnaire, that consists of 16 questions. Patients fill this assesment on a weekly basis during the study.
WHO-5
This Well-Being Index consists of five items that are scored on a frequency response scale from "none of the time" (0) to "all of the time" (5).
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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
