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

August 25, 2015 updated by: Per Bech, Hillerod Hospital, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hilleroed, Denmark, 3400
        • Psychiatric Research Unit, Mental Health Centre North Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active PEMF twice daily

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

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

Other Names:
  • T-PEMF = Transcranially applied PEMF
Active Comparator: Active PEMF once daily

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)

Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):

30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

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
Time Frame: Every week for 11 weeks
Interviewer based rating scale to measure severity of depression
Every week for 11 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillerod Hospital, Denmark

Investigators

  • Principal Investigator: Marianne Lunde, Coordinator, Mental Health Centre North Zealand Psychiatric Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26.04.2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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