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| Sponsors and Collaborators: |
Hillerod Hospital, Denmark The Lundbeckfoundation Biofields |
|---|---|
| Information provided by: | Hillerod Hospital, Denmark |
| ClinicalTrials.gov Identifier: | NCT00287703 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Active PEMF
|
Device: Pulsating Electro-Magnetic Fields
5 days a week for 5 weeks 30 minutes
|
|
2: Placebo Comparator
5 days a week for 5 weeks for 30 minutes Sham PEMF
|
Device: Pulsating Electro-Magnetic Fields sham
sham PEMF
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Klaus Martiny, MD, Ph.D. | +45 48293315 | kmar@fa.dk |
| Contact: Per Bech, MD, Professor | + 45 48293253 | pebe@fa.dk |
| Denmark | |
| Speciallægerne Falkoner Allé | Recruiting |
| Municipality of Fredericksburg, Denmark, 2000 | |
| Contact: Klaus Martiny, MD, Ph.D. +45 35373721 kmar@fa.dk | |
| Contact: Marianne Lunde +45 35373721 mlun@fa.dk | |
| Sub-Investigator: Marianne Lunde | |
| Principal Investigator: Klaus Martiny, MD, Ph.D. | |
| Principal Investigator: | Klaus Martiny, MD, Ph.D. | Psychiatric Research Unit Fredericksburg General Hospital |
More Information
| Responsible Party: | Psychiatric Research Unit, Hillerod Hospital ( Klaus Martiny ) |
| Study ID Numbers: | Final version 26 Oktober 2005 |
| Study First Received: | January 31, 2006 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00287703 History of Changes |
| Health Authority: | Denmark: Danish Medicines Agency |
|
Major depression Treatment resistant PEMF AQT Hamilton |
|
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
|
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
