Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression (PEMFII)
Primary Purpose
Treatment Resistant Depression
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Re5 Pulsating ElectroMagnetic Fields
Re5 Pulsating ElectroMagnetic Fields (PEMF)
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Randomized Controlled Trial, Major depression, Hamilton, PEMF
Eligibility 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
Sites / Locations
- Psychiatric Research Unit, Mental Health Centre North Zealand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active PEMF twice daily
Active PEMF once daily
Arm Description
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
Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Outcomes
Primary Outcome Measures
Hamilton depression rating scale
Interviewer based rating scale to measure severity of depression
Secondary Outcome Measures
UKU
Side effect scale
Full Information
NCT ID
NCT01353092
First Posted
April 27, 2011
Last Updated
August 25, 2015
Sponsor
Hillerod Hospital, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01353092
Brief Title
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hillerod Hospital, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
Randomized Controlled Trial, Major depression, Hamilton, PEMF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active PEMF twice daily
Arm Type
Experimental
Arm Description
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
Arm Title
Active PEMF once daily
Arm Type
Active Comparator
Arm Description
Re5 treatment helmet using Pulsating ElectroMagnetic Field:
Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Intervention Type
Device
Intervention Name(s)
Re5 Pulsating ElectroMagnetic Fields
Other Intervention Name(s)
T-PEMF = Transcranially applied PEMF
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Re5 Pulsating ElectroMagnetic Fields (PEMF)
Other Intervention Name(s)
T-PEMF = Transcranially applied PEMF
Intervention Description
Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):
30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Primary Outcome Measure Information:
Title
Hamilton depression rating scale
Description
Interviewer based rating scale to measure severity of depression
Time Frame
Every week for 11 weeks
Secondary Outcome Measure Information:
Title
UKU
Description
Side effect scale
Time Frame
Every week for 11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Lunde, Coordinator
Organizational Affiliation
Mental Health Centre North Zealand Psychiatric Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Research Unit, Mental Health Centre North Zealand
City
Hilleroed
ZIP/Postal Code
3400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20385376
Citation
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.
Results Reference
background
PubMed Identifier
26242577
Citation
Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 2015 Aug 5;15:190. doi: 10.1186/s12888-015-0529-3.
Results Reference
derived
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Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
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