Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06005103 |
| Other study ID # |
2215332 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 6, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Mental Health Services in the Capital Region, Denmark |
| Contact |
Martin B. Jørgensen, MD DMSc |
| Phone |
23328669 |
| Email |
Martin.Balslev.Joergensen[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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