Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Device: Re5 Pulsating ElectroMagnetic Fields
* Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active PEMF twice daily<br>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 | Device: Re5 Pulsating ElectroMagnetic Fields<br>* 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<br>* Other names: T-PEMF = Transcranially applied PEMF;|
| Active Comparator: Active PEMF once daily<br>Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon) | Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)<br>* Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)<br>* Other names: T-PEMF = Transcranially applied PEMF;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton depression rating scale | Interviewer based rating scale to measure severity of depression | Every week for 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UKU | Side effect scale | Every week for 11 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized Controlled Trial, Major depression, Hamilton, PEMF