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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:
Hillerod Hospital, Denmark
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
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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:
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00287703
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 |
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 August 22, 2017