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NCT Number: NCT01353092

Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

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.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Psychiatric Research Unit, Mental Health Centre North Zealand

Hilleroed, 3400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Re5 Pulsating ElectroMagnetic Fields

Device

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

Other names: T-PEMF = Transcranially applied PEMF

Re5 Pulsating ElectroMagnetic Fields (PEMF)

Device

Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):

30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

Other names: T-PEMF = Transcranially applied PEMF

Primary outcomes

  1. Hamilton depression rating scale

    Time frame: Every week for 11 weeks

    Interviewer based rating scale to measure severity of depression

Secondary outcomes

  1. UKU

    Time frame: Every week for 11 weeks

    Side effect scale

Sponsors and collaborators

Lead sponsor

Hillerod Hospital, Denmark

Other

Registry information

Official study title

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

Acronym: PEMFII

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 12, 2011
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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