NCT01353092

Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

PEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Hillerod Hospital, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DEVICE	Re5 Pulsating ElectroMagnetic Fields	Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon
DEVICE	Re5 Pulsating ElectroMagnetic Fields (PEMF)	Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-05-12
• Last updated: 2015-08-26

Locations

1 site across 1 country: Denmark