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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:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AQT, measure of concentration [ Time Frame: weekly ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 31, 2006
Last Updated: May 28, 2009
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on September 27, 2016