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REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by St. Lucas Andreas Ziekenhuis Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Lucas Andreas Ziekenhuis Hospital
ClinicalTrials.gov Identifier:
NCT00220610
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex.

We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales.

We hypothesized that rTMS has a positive effect in the treatment of depression


Condition Intervention Phase
Depression
 Device: Transcranial magnetic stimulation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Right Parietal Inhibition With rTMS in the Treatment of Depression

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by St. Lucas Andreas Ziekenhuis Hospital:

Primary Outcome Measures:
  • To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
  • Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)

Secondary Outcome Measures:
  • -Changes in anxiety
  • -.Autonomic changes
  • -.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
  • -.Biochemical changes
  • -.Changes in the EEG
  • >> measured before tms and after (at T=0 and T=2)

Estimated Enrollment: 40
Study Start Date: May 2004
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included

Exclusion Criteria:

  • A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study.

Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220610

Contacts
Contact: Judith van der Riet, Drs. 0031-20-5108562 j.vanderriet@slaz.nl

Locations
Netherlands
st. Lucas Andreas Ziekenhuis/ Hospital Recruiting
Amsterdam, Netherlands, 1061 AE
Contact: Judith van der Riet, Drs     0031-20-5108562     j.vanderriet@slaz.nl    
Contact: G.F Koerselman, Prof.dr.     0031-20-5108562     f.koerselman@slaz.nl    
Sponsors and Collaborators
St. Lucas Andreas Ziekenhuis Hospital
Investigators
Study Director: G.F Koerselman, prof. dr. st Lucas Andreas Ziekenhuis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220610     History of Changes
Other Study ID Numbers: CCMO03.3741/SH/P03.1231L
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013