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

This study has been completed.
Sponsor:
Collaborators:
The Lundbeckfoundation
Biofields
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00287703
First received: January 31, 2006
Last updated: May 28, 2009
Last verified: May 2009

January 31, 2006
May 28, 2009
March 2006
March 2009   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale score (depression) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Hamilton depression rating scale score (depression)
  • AQT time to complete test in seconds (concentration)
Complete list of historical versions of study NCT00287703 on ClinicalTrials.gov Archive Site
AQT, measure of concentration [ Time Frame: weekly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Device: Pulsating Electro-Magnetic Fields
    5 days a week for 5 weeks 30 minutes
  • Device: Pulsating Electro-Magnetic Fields sham
    sham PEMF
  • Experimental: 1
    Active Pulsating Electro Magnetic Fields (PEMF) treatment
    Intervention: Device: Pulsating Electro-Magnetic Fields
  • Sham Comparator: 2
    5 days a week for 5 weeks for 30 minutes Sham PEMF
    Intervention: Device: Pulsating Electro-Magnetic Fields sham
Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00287703
Final version 26 Oktober 2005
Yes
Klaus Martiny, Psychiatric Research Unit, Hillerod Hospital
Hillerod Hospital, Denmark
  • The Lundbeckfoundation
  • Biofields
Principal Investigator: Klaus Martiny, MD, Ph.D. Psychiatric Research Unit Fredericksburg General Hospital
Hillerod Hospital, Denmark
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP