Using a headband to treat moderate to severe depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of transcranial pulsed electromagnetic fields (T-PEMF) on patients with moderate to severe depression using a device called the MoodHeadBand (MHB). Over an 8-week period, participants will use either the active MHB or a placebo for 30 minutes daily. The study aims to assess the antidepressant effects, cognitive improvements, and potential benefits for restorative sleep associated with T-PEMF treatment. Participants will be monitored through weekly follow-ups and surveys to evaluate their depression severity and treatment response.

Why it matters

Who can join: the full rules

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

Where it's running

• Psychiatric Center Copenhagen
  Frederiksberg, Capital Region, Denmark Recruiting

Study contacts

• Principal investigator: Martin B. Jørgensen, MD MSc — Psychiatric Center Copenhagen
• Study coordinator: Martin B. Jørgensen, MD DMSc
• Email: Martin.Balslev.Joergensen@regionh.dk
• Phone: 23328669

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.