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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287703
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : May 29, 2009
Sponsor:
Collaborators:
The Lundbeckfoundation
Biofields
Information provided by:
Hillerod Hospital, Denmark

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 7, 2006
Last Update Posted Date May 29, 2009
Study Start Date  ICMJE March 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Hamilton Depression Rating Scale score (depression) [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
  • Hamilton Depression Rating Scale score (depression)
  • AQT time to complete test in seconds (concentration)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
AQT, measure of concentration [ Time Frame: weekly ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Official Title  ICMJE Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Device: Pulsating Electro-Magnetic Fields
    5 days a week for 5 weeks 30 minutes
  • Device: Pulsating Electro-Magnetic Fields sham
    sham PEMF
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00287703
Other Study ID Numbers  ICMJE Final version 26 Oktober 2005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Klaus Martiny, Psychiatric Research Unit, Hillerod Hospital
Study Sponsor  ICMJE Hillerod Hospital, Denmark
Collaborators  ICMJE
  • The Lundbeckfoundation
  • Biofields
Investigators  ICMJE
Principal Investigator: Klaus Martiny, MD, Ph.D. Psychiatric Research Unit Fredericksburg General Hospital
PRS Account Hillerod Hospital, Denmark
Verification Date May 2009

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