NCT01353092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

April 27, 2011

Last Update Submit

August 25, 2015

Conditions

Treatment Resistant Depression

Keywords

Randomized Controlled TrialMajor depressionHamiltonPEMF

Outcome Measures

Primary Outcomes (1)

  • Hamilton depression rating scale

    Interviewer based rating scale to measure severity of depression

    Every week for 11 weeks

Secondary Outcomes (1)

  • UKU

    Every week for 11 weeks

Study Arms (2)

Active PEMF twice daily

EXPERIMENTAL

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

Active PEMF once daily

ACTIVE COMPARATOR

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)

Interventions

Re5 Pulsating ElectroMagnetic FieldsDEVICE

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
Active PEMF twice daily
Re5 Pulsating ElectroMagnetic Fields (PEMF)DEVICE

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
Active PEMF once daily

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Unit, Mental Health Centre North Zealand

Hilleroed, 3400, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 20385376BACKGROUND

  • 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.

    PMID: 26242577DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Marianne Lunde, Coordinator

    Mental Health Centre North Zealand Psychiatric Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2011

First Posted

May 12, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

DK(1)