|- candidate number||1394|
|- NTR Number||NTR224|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||5-sep-2005|
|- Secondary IDs||CCMO03.3741/SH/P03.1231L |
|- Public Title||Repetitive transcranial magnetic stimulation in the treatment of depression.|
|- Scientific Title||Right parietal inhibition with rTMS in the treatment of depression.|
|- hypothesis||rTMS has a positive effect in the treatment of depression.|
|- Healt Condition(s) or Problem(s) studied||Depression|
|- 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||Exclusion 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2004|
|- planned closingdate||1-dec-2006|
|- Target number of participants||40|
|- Interventions||REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session. |
|- Primary outcome||Depression.|
|- Secondary outcome||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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. J. Riet, van der|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD G.F. Koerselman|
|- Sponsor/Initiator ||St. Lucas Andreas Hospital, Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|- 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.
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 14-sep-2009|