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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287703
• Other study ID #: Final version 26 Oktober 2005
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2006
• Last updated: May 28, 2009
• Start date: March 2006
• Est. completion date: March 2009

Study information

• Verified date: May 2009
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• Pulsating Electro-Magnetic Fields
5 days a week for 5 weeks 30 minutes
• Pulsating Electro-Magnetic Fields sham
sham PEMF

Locations

Country	Name	City	State
Denmark	Speciallægerne Falkoner Allé	Municipality of Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark	Biofields, The Lundbeckfoundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale score (depression)		1 week	No
Secondary	AQT, measure of concentration		weekly	No