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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hillerod Hospital, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01353092
First received: April 27, 2011
Last updated: May 11, 2011
Last verified: January 2011
  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 treatment helmet using Pulsating ElectroMagnetic Fields
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


Estimated Enrollment: 62
Study Start Date: April 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active PEMF twice daily
30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon
Device: Re5 treatment helmet using Pulsating ElectroMagnetic Fields
Helmet containing seven coils connected to a pulse generator delivering pulsating electromagnetic fields Producer of helmet is Re5
Other Name: T-PEMF = Transcranially applied PEMF
Active Comparator: Active PEMF once daily
30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Device: Re5 treatment helmet using Pulsating ElectroMagnetic Fields

Helmet containing seven coils connected to a pulse generator delivering pulsating electromagnetic fields.

Producer of helmet is Re5

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

Contacts
Contact: Per Bech, Professor +45-48293253 per.bech@regionh.dk

Locations
Denmark
Psychiatric Research Unit, Mental Health Centre North Zealand Recruiting
Hilleroed, Denmark, 3400
Contact: Per Bech, Professor    +45-48293253    per.bech@regionh.dk   
Sponsors and Collaborators
Hillerod Hospital, Denmark
Investigators
Principal Investigator: Marianne Lunde, Coordinator Mental Health Centre North Zealand Psychiatric Research Unit
  More Information

Publications:
Responsible Party: Per Bech, Mental Health Centre North Zealand, Psychiatric Research unit
ClinicalTrials.gov Identifier: NCT01353092     History of Changes
Other Study ID Numbers: 26.04.2010
Study First Received: April 27, 2011
Last Updated: May 11, 2011
Health Authority: Denmark: The research ethics committees 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
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014