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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:
ClinicalTrials.gov Identifier:
NCT00287703
First Posted: February 7, 2006
Last Update Posted: May 29, 2009
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.
Collaborators:
The Lundbeckfoundation
Biofields
Information provided by:
Hillerod Hospital, Denmark
  Purpose
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.

Condition Intervention Phase
Depression Device: Pulsating Electro-Magnetic Fields Device: Pulsating Electro-Magnetic Fields sham Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale score (depression) [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • AQT, measure of concentration [ Time Frame: weekly ]
Enrollment: 50
Study Start Date: March 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active Pulsating Electro Magnetic Fields (PEMF) treatment
 Device: Pulsating Electro-Magnetic Fields
5 days a week for 5 weeks 30 minutes
Sham Comparator: 2
5 days a week for 5 weeks for 30 minutes Sham PEMF
 Device: Pulsating Electro-Magnetic Fields sham
sham PEMF

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287703


Locations
Denmark
Speciallægerne Falkoner Allé
Municipality of Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Hillerod Hospital, Denmark
The Lundbeckfoundation
Biofields
Investigators
Principal Investigator: Klaus Martiny, MD, Ph.D. Psychiatric Research Unit Fredericksburg General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Klaus Martiny, Psychiatric Research Unit, Hillerod Hospital
ClinicalTrials.gov Identifier: NCT00287703     History of Changes
Other Study ID Numbers: Final version 26 Oktober 2005
First Submitted: January 31, 2006
First Posted: February 7, 2006
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by Hillerod Hospital, Denmark:
Major depression
Treatment resistant
PEMF
AQT
Hamilton

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders