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. Identifier: NCT00220610
Recruitment Status : Unknown
Verified September 2005 by St. Lucas Andreas Ziekenhuis Hospital.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Information provided by:
St. Lucas Andreas Ziekenhuis Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Depression Device: Transcranial magnetic stimulation Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Right Parietal Inhibition With rTMS in the Treatment of Depression
Study Start Date : May 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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)
  2. Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)

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

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00220610

Contact: Judith van der Riet, Drs. 0031-20-5108562

st. Lucas Andreas Ziekenhuis/ Hospital Recruiting
Amsterdam, Netherlands, 1061 AE
Contact: Judith van der Riet, Drs    0031-20-5108562   
Contact: G.F Koerselman, Prof.dr.    0031-20-5108562   
Sponsors and Collaborators
St. Lucas Andreas Ziekenhuis Hospital
Study Director: G.F Koerselman, prof. dr. st Lucas Andreas Ziekenhuis Identifier: NCT00220610     History of Changes
Other Study ID Numbers: CCMO03.3741/SH/P03.1231L
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005

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