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

Phase 3

Completed

• Conditions: Depression
• Interventions: Device: Pulsating Electro-Magnetic Fields; Device: Pulsating Electro-Magnetic Fields sham

• Registration Number: NCT00287703
• Lead Sponsor: Hillerod Hospital, Denmark

Brief Summary

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

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 Timeline

• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Study Start: 2006-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-28
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pulsating Electro-Magnetic Fields	Active Pulsating Electro Magnetic Fields (PEMF) treatment
2	Pulsating Electro-Magnetic Fields sham	5 days a week for 5 weeks for 30 minutes Sham PEMF

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale score (depression)	1 week

Secondary Outcome Measures

Name	Time	Method
AQT, measure of concentration	weekly

Trial Locations

Locations (1)

Speciallægerne Falkoner Allé; 🇩🇰 Municipality of Frederiksberg, Denmark