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History of Changes for Study: NCT00287703
PEMF in Refractory Major Depression
Latest version (submitted May 28, 2009) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 6, 2006 None (earliest Version on record)
2 June 20, 2007 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Study Design, Oversight and Study Identification
3 December 21, 2007 Arms and Interventions, Study Status, Outcome Measures, Study Design and Sponsor/Collaborators
4 April 25, 2008 Contacts/Locations, Study Description, Study Status, Study Identification, Eligibility and Outcome Measures
5 April 29, 2008 Contacts/Locations, Outcome Measures, Arms and Interventions and Study Status
6 January 27, 2009 Study Status and Arms and Interventions
7 May 28, 2009 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Study Design
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Study NCT00287703
Submitted Date:  February 6, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: Final version 26 Oktober 2005
Brief Title: PEMF in Refractory Major Depression
Official Title: PEMF Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2005
Overall Status: Not yet recruiting
Study Start: March 2006
Primary Completion:
Study Completion: April 2007
First Submitted: January 31, 2006
First Submitted that
Met QC Criteria:
February 6, 2006
First Posted: February 7, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 6, 2006
Last Update Posted: February 7, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hillerod Hospital, Denmark
Responsible Party:
Collaborators: The Lundbeckfoundation
Biofields
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: About 30% of patients with major depression are treatment resistant to pharmacological treatment.In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = Pulsed Electro Magnetic Fields) can aleviate the symptoms of depression.
Detailed Description: In this study, patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severety is measured at the beginning of the study and at each weekly visit. Side effects is closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).
Open or close this module Conditions
Conditions: Depression
Keywords: Major depression
Treatment resistant
PEMF
AQT
Hamilton
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 50
Open or close this module Arms and Interventions
Intervention Details:
Device: PEMF
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Hamilton depression rating scale score (depression)
2. AQT time to complete test in seconds (concentration)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Major Depression
  • Treatment resistance
  • Age above 18 years
  • Hamilton 17 item score above 13
  • Unaltered pharmacological treatment in last 4 weeks

Exclusion Criteria:

  • Psychotic disorder
  • Mental retardation
  • Suicidality
  • Earlier treatment with PEMF
  • Abuse of alcohol or other substances
  • Patient not able to come to appointed visits
  • Antisocial, Borderline or Schizotypic personality disorder
  • Women lactation or pregnant
  • Unreliable contraception
Open or close this module Contacts/Locations
Central Contact Person: Klaus Martiny, MD Ph.D.
Telephone: +45 48293315
Email: kmar@fa.dk
Central Contact Backup: Per Martiny, MD Professor
Telephone: + 45 48293253
Email: pebe@fa.dk
Study Officials: Klaus Martiny, MD Ph.D.
Principal Investigator
Psychiatric Researc Unit Frederiksborg General Hospital
Locations: Denmark
"Speciallægerne Falkoner Allé"
Municipality of Frederiksberg, Denmark, 2000
Contact:Contact: Klaus Martiny, MD Ph.D. +45 35373721 kmar@fa.dk
Contact:Contact: Marianne Lunde +45 35373721 mlun@fa.dk
Contact:Sub-Investigator: Marianne Lunde
Contact:Principal Investigator: Klaus Martiny, MD Ph.D.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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