Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Treatment Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Re5 Pulsating ElectroMagnetic Fields

Intervention Type DEVICE

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

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)

Group Type ACTIVE_COMPARATOR

Re5 Pulsating ElectroMagnetic Fields (PEMF)

Intervention Type DEVICE

Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):

30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)

Interventions

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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

Intervention Type 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)

Intervention Type DEVICE

Other Intervention Names

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T-PEMF = Transcranially applied PEMF T-PEMF = Transcranially applied PEMF

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No