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REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by St. Lucas Andreas Ziekenhuis Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220610
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Lucas Andreas Ziekenhuis Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Right Parietal Inhibition With rTMS in the Treatment of Depression

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00220610     History of Changes
Other Study ID Numbers: CCMO03.3741/SH/P03.1231L
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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