Status:
RECRUITING
A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Collaborating Sponsors:
Innovation Fund Denmark
Danish Medical Association
Conditions:
Moderate Depression
Severe Depressive Episode Without Psychotic Symptoms
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 s...
Detailed Description
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06005103
Start Date
June 17 2024
End Date
August 30 2026
Last Update
August 26 2025
Active Locations (1)
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1
Psychiatric Center Copenhagen
Frederiksberg, Capital Region, Denmark, 2600