Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 depression
Started Mar 2006
Typical duration for phase_3 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedMay 29, 2009
May 1, 2009
3 years
January 31, 2006
May 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale score (depression)
1 week
Secondary Outcomes (1)
AQT, measure of concentration
weekly
Study Arms (2)
1
EXPERIMENTALActive Pulsating Electro Magnetic Fields (PEMF) treatment
2
SHAM COMPARATOR5 days a week for 5 weeks for 30 minutes Sham PEMF
Interventions
Eligibility Criteria
You may qualify if:
- Major depression
- Treatment resistance
- Age above 18 years
- Hamilton 17 item score above 13
- Unaltered pharmacological treatment in last 4 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hillerod Hospital, Denmarklead
- The Lundbeckfoundationcollaborator
- Biofieldscollaborator
Study Sites (1)
Speciallægerne Falkoner Allé
Municipality of Frederiksberg, 2000, Denmark
Related Publications (1)
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.
PMID: 20385376DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Martiny, MD, Ph.D.
Psychiatric Research Unit Fredericksburg General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 7, 2006
Study Start
March 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 29, 2009
Record last verified: 2009-05