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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Per Bech, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01353092
First received: April 27, 2011
Last updated: August 25, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention Phase
Treatment Resistant Depression
Device: Re5 Pulsating ElectroMagnetic Fields
Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Hamilton depression rating scale [ Time Frame: Every week for 11 weeks ] [ Designated as safety issue: No ]
    Interviewer based rating scale to measure severity of depression


Secondary Outcome Measures:
  • UKU [ Time Frame: Every week for 11 weeks ] [ Designated as safety issue: Yes ]
    Side effect scale


Enrollment: 65
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: T-PEMF = Transcranially applied PEMF

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353092

Locations
Denmark
Psychiatric Research Unit, Mental Health Centre North Zealand
Hilleroed, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Investigators
Principal Investigator: Marianne Lunde, Coordinator Mental Health Centre North Zealand Psychiatric Research Unit
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Bech, Professor, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01353092     History of Changes
Other Study ID Numbers: 26.04.2010
Study First Received: April 27, 2011
Last Updated: August 25, 2015
Health Authority: Denmark: Mental Health Services in the Capital Region of Denmark

Keywords provided by Hillerod Hospital, Denmark:
Randomized Controlled Trial
Major depression
Hamilton
PEMF

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on September 02, 2015