Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression

Study Overview
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Brief Summary
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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
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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).

Official Title
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Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Pulsating Electro-Magnetic Fields
* Device: Pulsating Electro-Magnetic Fields sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Active Pulsating Electro Magnetic Fields (PEMF) treatment | Device: Pulsating Electro-Magnetic Fields<br>* 5 days a week for 5 weeks 30 minutes<br>|
| Sham Comparator: 2<br>5 days a week for 5 weeks for 30 minutes Sham PEMF | Device: Pulsating Electro-Magnetic Fields sham<br>* sham PEMF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale score (depression) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AQT, measure of concentration |  | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AQT, Major depression, Treatment resistant, PEMF, Hamilton