Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
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ClinicalTrials.gov Identifier: NCT00287703 |
Recruitment Status :
Completed
First Posted : February 7, 2006
Last Update Posted : May 29, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression | Device: Pulsating Electro-Magnetic Fields Device: Pulsating Electro-Magnetic Fields sham | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
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 |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
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
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Device: Pulsating Electro-Magnetic Fields sham
sham PEMF |
- Hamilton Depression Rating Scale score (depression) [ Time Frame: 1 week ]
- AQT, measure of concentration [ Time Frame: weekly ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287703
Denmark | |
Speciallægerne Falkoner Allé | |
Municipality of Frederiksberg, Denmark, 2000 |
Principal Investigator: | Klaus Martiny, MD, Ph.D. | Psychiatric Research Unit Fredericksburg General Hospital |
Responsible Party: | Klaus Martiny, Psychiatric Research Unit, Hillerod Hospital |
ClinicalTrials.gov Identifier: | NCT00287703 |
Other Study ID Numbers: |
Final version 26 Oktober 2005 |
First Posted: | February 7, 2006 Key Record Dates |
Last Update Posted: | May 29, 2009 |
Last Verified: | May 2009 |
Major depression Treatment resistant PEMF AQT Hamilton |
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |