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

April 27, 2011
August 25, 2015
April 2011
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01353092 on ClinicalTrials.gov Archive Site
UKU [ Time Frame: Every week for 11 weeks ] [ Designated as safety issue: Yes ]
Side effect scale
Same as current
Not Provided
Not Provided
 
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Treatment Resistant Depression
  • 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
  • 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
  • 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

    Intervention: Device: Re5 Pulsating ElectroMagnetic Fields
  • 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)

    Intervention: Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01353092
26.04.2010
Yes
Per Bech, Hillerod Hospital, Denmark
Hillerod Hospital, Denmark
Not Provided
Principal Investigator: Marianne Lunde, Coordinator Mental Health Centre North Zealand Psychiatric Research Unit
Hillerod Hospital, Denmark
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP