Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

PEMF 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01353092

Acronym

PEMFII

Enrollment

Registered

2011-05-12

Start date

2011-04-30

Completion date

2013-06-30

Last updated

2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Depression

Keywords

Randomized Controlled Trial, Major depression, Hamilton, PEMF

Brief summary

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.

Interventions

DEVICERe5 Pulsating ElectroMagnetic Fields

Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon

DEVICERe5 Pulsating ElectroMagnetic Fields (PEMF)

Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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 * pregnant or lactating women * insufficient birth control measures

Design outcomes

Primary

Measure	Time frame	Description
Hamilton depression rating scale	Every week for 11 weeks	Interviewer based rating scale to measure severity of depression

Secondary

Measure	Time frame	Description
UKU	Every week for 11 weeks	Side effect scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026