- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01353092
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression (PEMFII)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Hilleroed, Denmark, 3400
- Psychiatric Research Unit, Mental Health Centre North Zealand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
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 Names:
|
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) |
Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton depression rating scale
Time Frame: Every week for 11 weeks
|
Interviewer based rating scale to measure severity of depression
|
Every week for 11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UKU
Time Frame: Every week for 11 weeks
|
Side effect scale
|
Every week for 11 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marianne Lunde, Coordinator, Mental Health Centre North Zealand Psychiatric Research Unit
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26.04.2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Treatment Resistant Depression
-
Changping LaboratoryBeijing HuiLongGuan HospitalRecruitingTreatment-Resistant DepressionChina
-
Central Institute of Mental Health, MannheimCharite University, Berlin, Germany; German Federal Ministry of Education and... and other collaboratorsActive, not recruitingTreatment-resistant DepressionGermany
-
Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, Australia, France, United Kingdom, Belgium, Germany, Taiwan, Spain, Argentina, Mexico, Poland, Bulgaria, Malaysia, South Africa, Turkey, Finland, Korea, Republic of, Brazil, Austria, Sweden, Lithuania
-
Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, France, Belgium, Mexico, Canada, Brazil, Estonia, Hungary, Slovakia
-
University of OttawaCanadian Institutes of Health Research (CIHR)Completed
-
GH Research Ireland LimitedRecruitingTreatment-resistant DepressionIreland, Czechia
-
First Affiliated Hospital of Zhejiang UniversityRecruitingTreatment-resistant DepressionChina
-
University Hospital FreiburgBoston Scientific CorporationRecruitingTreatment-resistant DepressionGermany, France
-
Janssen Research & Development, LLCCompletedTreatment-resistant DepressionUnited States, Poland, Germany, Spain, Czechia
-
Millennium Pharmaceuticals, Inc.WithdrawnTreatment-Resistant Depression
Clinical Trials on Re5 Pulsating ElectroMagnetic Fields
-
The Danish Research Centre for Chemical SensitivitiesAage Bangs FondCompletedMultiple Chemical SensitivityDenmark
-
Odense University HospitalCompletedTranscranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's DiseaseParkinson DiseaseDenmark
-
Hillerod Hospital, DenmarkThe Lundbeckfoundation; BiofieldsCompleted
-
Pamukkale UniversityCompleted
-
Charite University, Berlin, GermanySeibersdorf Labor GmbHSuspended
-
Pasche, Boris, M.D.Barbault, Alexandre, M.S.CompletedCancer | Brain TumorSwitzerland
-
University of Padova, School of Dental MedicineCompletedPain | Oral Surgery | Third Molar Extraction
-
University of MessinaCompleted
-
National University Hospital, SingaporeNational University, SingaporeRecruitingObesity | Type 2 DiabetesSingapore
-
Pasche, Boris, M.D.Barbault, Alexandre, M.S.TerminatedCarcinoma, HepatocellularSwitzerland