Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

Phase 3

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Device: Re5 Pulsating ElectroMagnetic Fields; Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)

• Registration Number: NCT01353092
• Lead Sponsor: Hillerod Hospital, Denmark

Brief Summary

In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Treatment resistant Major depression (grade 3 Sackeim criteria)
• Age above 18 and below 85
• Hamilton (17 item version) score above 12
• Unchanged psychopharmacological treatment for last five weeks.

Exclusion Criteria

• suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment
• dementia or similar cognitive impairment
• psychotic disorder
• abuse of alcohol or drugs
• pregnant or lactating women
• insufficient birth control measures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active PEMF twice daily	Re5 Pulsating ElectroMagnetic Fields	Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon
Active PEMF once daily	Re5 Pulsating ElectroMagnetic Fields (PEMF)	Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

Primary Outcome Measures

Name	Time	Method
Hamilton depression rating scale	Every week for 11 weeks	Interviewer based rating scale to measure severity of depression

Secondary Outcome Measures

Name	Time	Method
UKU	Every week for 11 weeks	Side effect scale

Trial Locations

Locations (1)

Psychiatric Research Unit, Mental Health Centre North Zealand; 🇩🇰 Hilleroed, Denmark