Overview
This study is a blinded 8-week, randomized trial conducted to clarify whether treatment with brain stimulation for half an hour daily for eight weeks with a headband with weak pulsating electromagnetic fields (T-PEMF) can achieve a safe effect on depression compared to the same treatment with a placebo T-PEMF.
Description
The study will take place at Psychiatric Center Copenhagen. The purpose of this study is to clarify whether daily treatment over eight weeks with weak pulsating electromagnetic fields (T-PEMF) can achieve a safe effect on depression compared to the same treatment with a placebo T-PEMF. Previous Danish studies have shown a significant effect in the treatment of patients with treatment-resistant depression. There are no studies, neither in Denmark nor in the world, which demonstrate an effect on the early stages in the development of depressive disorders.
The study is designed as a blinded, randomized study where active treatment is compared with inactive (sham) treatment. At the same time, possible side effects in the use of the headband (MoodHeadBand, MHB) are investigated.
The project starts in May 2023. The aim is for 80 patients to be included in the study.
Patients consecutively referred are asked after an initial interview whether they wish to participate in the study. If they give informed consent to this, they will be randomized to active or sham treatment. The treatment itself takes place at home, 30 minutes once a day, for 8 weeks. "Treatment as usual" takes place in parallel to the study treatment, and consists of psychotherapy in the form of Cognitive Behavioral Therapy (CBT) in a group or individually and antidepressive medications.
At the start, the clinical diagnosis is obtained and validated with a structured interview, to ensure that the diagnostic criteria for the diagnosis are present and that the exclusion criteria are not present. The degree of depression is examined with Hamilton's Depression Scale (HAM-D17), and Inventory of Depressive Symptomatology (IDS-SR). Quality of life (WHO-5) and degree of side effects (UKU-24) are included.
Changes in the level of depression and side effects are measured by the Quick Inventory of Depressive Symptomatology (QIDS16-SR) every week after the start of treatment The degree of any side effects is measured at baseline and weeks 1, 2, 4, 6, and 8 by UKU-24.
At the end of the treatment, the degree of depression is examined again using the HAM-D17, IDS-SR, and quality of life (WHO-5). The degree of satisfaction with the use of MHB is examined on a scale from 1-7.
No significant side effects have been registered when using the same type of magnetic field treatment in the previous Danish studies. It has also been shown that it is possible to carry out the treatment at home without significant problems.
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