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

Hillerod Hospital, Denmark

Status and phase: Completed; Phase 3

Conditions: Treatment Resistant Depression

Treatments: Device: Re5 Pulsating ElectroMagnetic Fields (PEMF); Device: Re5 Pulsating ElectroMagnetic Fields

Study type: Interventional

Funder types: Other

Identifiers

NCT01353092

26.04.2010

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups

Active PEMF twice daily

Experimental group

Description:

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

Treatment:

Device: Re5 Pulsating ElectroMagnetic Fields

Active PEMF once daily

Active Comparator group

Description:

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

Treatment:

Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)