- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287703
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
May 28, 2009 updated by: Hillerod Hospital, Denmark
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Municipality of Frederiksberg, Denmark, 2000
- Speciallægerne Falkoner Allé
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Active Pulsating Electro Magnetic Fields (PEMF) treatment
|
5 days a week for 5 weeks 30 minutes
|
Sham Comparator: 2
5 days a week for 5 weeks for 30 minutes Sham PEMF
|
sham PEMF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Depression Rating Scale score (depression)
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AQT, measure of concentration
Time Frame: weekly
|
weekly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Klaus Martiny, MD, Ph.D., Psychiatric Research Unit Fredericksburg General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
January 31, 2006
First Submitted That Met QC Criteria
February 6, 2006
First Posted (Estimate)
February 7, 2006
Study Record Updates
Last Update Posted (Estimate)
May 29, 2009
Last Update Submitted That Met QC Criteria
May 28, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Final version 26 Oktober 2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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