Back to resultsPulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Pulsating Electro-Magnetic Fields
Pulsating Electro-Magnetic Fields sham
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Major depression, Treatment resistant, PEMF, AQT, Hamilton
Eligibility 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
Sites / Locations
- Speciallægerne Falkoner Allé
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
Active Pulsating Electro Magnetic Fields (PEMF) treatment
5 days a week for 5 weeks for 30 minutes Sham PEMF
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale score (depression)
Secondary Outcome Measures
AQT, measure of concentration
Full Information
NCT ID
NCT00287703
First Posted
January 31, 2006
Last Updated
May 28, 2009
Sponsor
Hillerod Hospital, Denmark
Collaborators
The Lundbeckfoundation, Biofields
1. Study Identification
Unique Protocol Identification Number
NCT00287703
Brief Title
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Official Title
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hillerod Hospital, Denmark
Collaborators
The Lundbeckfoundation, Biofields
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major depression, Treatment resistant, PEMF, AQT, Hamilton
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Active Pulsating Electro Magnetic Fields (PEMF) treatment
Arm Title
2
Arm Type
Sham Comparator
Arm Description
5 days a week for 5 weeks for 30 minutes Sham PEMF
Intervention Type
Device
Intervention Name(s)
Pulsating Electro-Magnetic Fields
Intervention Description
5 days a week for 5 weeks 30 minutes
Intervention Type
Device
Intervention Name(s)
Pulsating Electro-Magnetic Fields sham
Intervention Description
sham PEMF
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale score (depression)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
AQT, measure of concentration
Time Frame
weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Martiny, MD, Ph.D.
Organizational Affiliation
Psychiatric Research Unit Fredericksburg General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Speciallægerne Falkoner Allé
City
Municipality of Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20385376
Citation
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.
Results Reference
derived
Learn more about this trial
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
We'll reach out to this number within 24 hrs