Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

Treatment Resistant Depression Clinical Trial

— PEMFII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353092
• Other study ID #: 26.04.2010
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2011
• Last updated: August 25, 2015
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Mental Health Services in the Capital Region of Denmark
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

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
• 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)

Locations

Country	Name	City	State
Denmark	Psychiatric Research Unit, Mental Health Centre North Zealand	Hilleroed

Sponsors (1)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression rating scale	Interviewer based rating scale to measure severity of depression	Every week for 11 weeks	No
Secondary	UKU	Side effect scale	Every week for 11 weeks	Yes