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Repetitive transcranial magnetic stimulation in the treatment of depression.


- candidate number1394
- NTR NumberNTR224
- ISRCTNISRCTN13548185
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsCCMO03.3741/SH/P03.1231L  
- Public TitleRepetitive transcranial magnetic stimulation in the treatment of depression.
- Scientific TitleRight parietal inhibition with rTMS in the treatment of depression.
- ACRONYMTMS
- hypothesisrTMS has a positive effect in the treatment of depression.
- Healt Condition(s) or Problem(s) studiedDepression
- Inclusion criteriaIn 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 criteriaExclusion criteria were 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: schizofrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2004
- planned closingdate1-dec-2006
- Target number of participants40
- InterventionsREPETITIVE TRANSCRANIAL MAGNETIC STIMULATION daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.
- Primary outcomeDepression.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. J. Riet, van der
- CONTACT for SCIENTIFIC QUERIESMD PhD G.F. Koerselman
- Sponsor/Initiator St. Lucas Andreas Hospital, Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summarySubjects 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.
- Main changes (audit trail)
- RECORD6-sep-2005 - 14-sep-2009


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