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Completed

NCT Number: NCT00287703

Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression

About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Speciallægerne Falkoner Allé

Municipality of Frederiksberg, 2000, Denmark

About this study

In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Major depression
  • Treatment resistance
  • Age above 18 years
  • Hamilton 17 item score above 13
  • Unaltered pharmacological treatment in last 4 weeks

Exclusion criteria

  • Psychotic disorder
  • Mental retardation
  • Suicidality
  • Earlier treatment with PEMF
  • Abuse of alcohol or other substances
  • Patient not able to come to appointed visits
  • Antisocial, borderline or schizotypic personality disorder
  • Women lactating or pregnant
  • Unreliable contraception

Treatment and study plan

Pulsating Electro-Magnetic Fields

Device

5 days a week for 5 weeks 30 minutes

Pulsating Electro-Magnetic Fields sham

Device

sham PEMF

Primary outcomes

  1. Hamilton Depression Rating Scale score (depression)

    Time frame: 1 week

Secondary outcomes

  1. AQT, measure of concentration

    Time frame: weekly

Sponsors and collaborators

Lead sponsor

Hillerod Hospital, Denmark

Other

Collaborators

  • Biofields
  • The Lundbeckfoundation

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 7, 2006
Registry last updated
May 29, 2009

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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