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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00287703

Enrollment

Registered

2006-02-07

Start date

2006-03-31

Completion date

2009-03-31

Last updated

2009-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Major depression, Treatment resistant, PEMF, AQT, Hamilton

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).

Interventions

DEVICEPulsating Electro-Magnetic Fields

5 days a week for 5 weeks 30 minutes

DEVICEPulsating Electro-Magnetic Fields sham

sham PEMF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale score (depression)	1 week

Secondary

Measure	Time frame
AQT, measure of concentration	weekly

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026