A Phase 3 interventional study of Re5 Pulsating ElectroMagnetic Fields and Re5 Pulsating ElectroMagnetic Fields (PEMF) in Treatment Resistant Depression, sponsored by Hillerod Hospital, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-08-26.
Sponsored by Hillerod Hospital, Denmark · Phase 3, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 65 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Hillerod Hospital, Denmark is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Device: Re5 Pulsating ElectroMagnetic Fields
Re5 treatment helmet using Pulsating ElectroMagnetic Field: Intervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)
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
Also known as: T-PEMF = Transcranially applied PEMF
Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF): 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Also known as: T-PEMF = Transcranially applied PEMF
Hamilton depression rating scale
Interviewer based rating scale to measure severity of depression
Time frame: Every week for 11 weeks
UKU
Side effect scale
Time frame: Every week for 11 weeks
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Hillerod Hospital, Denmark