Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression (PEMFII)

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

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.

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

Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

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

Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

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

Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.

Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 2015 Aug 5;15:190. doi: 10.1186/s12888-015-0529-3.