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

Hillerod Hospital, Denmark

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Device: Pulsating Electro-Magnetic Fields; Device: Pulsating Electro-Magnetic Fields sham

Study type: Interventional

Funder types: Other

Identifiers

NCT00287703

Final version 26 Oktober 2005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups

1

Experimental group

Description:

Active Pulsating Electro Magnetic Fields (PEMF) treatment

Treatment:

Device: Pulsating Electro-Magnetic Fields

2

Sham Comparator group

Description:

5 days a week for 5 weeks for 30 minutes Sham PEMF

Treatment:

Device: Pulsating Electro-Magnetic Fields sham