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Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

NCT01353092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2015-08-26

No results posted yet for this study

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.

Conditions

Interventions

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

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)

Sponsors & Collaborators

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Marianne Lunde, Coordinator · Mental Health Centre North Zealand Psychiatric Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Denmark

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353092 on ClinicalTrials.gov