Completed

PEMFIIPEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Re5 Pulsating ElectroMagnetic Fields

+ Re5 Pulsating ElectroMagnetic Fields (PEMF)

Device
Who is being recruted

Mental Disorders+2

+ Depressive Disorder, Major

+ Depressive Disorder

From 18 to 85 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorHillerod Hospital, Denmark
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.

Official TitlePEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks
NCT01353092
Principal SponsorHillerod Hospital, Denmark
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

65 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive Disorder, MajorDepressive DisorderMood DisordersDepressive Disorder, Treatment-Resistant

Criteria

4 inclusion criteria required to participate
Treatment resistant Major depression (grade 3 Sackeim criteria)
Age above 18 and below 85
Hamilton (17 item version) score above 12
Unchanged psychopharmacological treatment for last five weeks.
6 exclusion criteria prevent from participating
suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment
dementia or similar cognitive impairment
psychotic disorder
abuse of alcohol or drugs
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon

Group II

Active Comparator
Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Psychiatric Research Unit, Mental Health Centre North Zealand

Hilleroed, DenmarkOpen Psychiatric Research Unit, Mental Health Centre North Zealand in Google Maps
CompletedOne Study Center