T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression
Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate
About this trial
This is an interventional treatment trial for Moderate Depression focused on measuring Randomized Controlled Trial, Depression, Transcranial Pulsed Electro-Magnetic Fields (T-PEMF), Psychiatry
Eligibility Criteria
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
Sites / Locations
- Psychiatric Center CopenhagenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active treatment with T-PEMF (Active)
Inactive treatment with T-PEMF (sham)
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.
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.