The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to ECT
The aim of the present study is to compare the antidepressant effect of electroconvulsive therapy ( ECT) with that of low frequency repetitive transcranial magnetic stimulation of the right prefrontal cortex.
In the same study we investigate the value of saliva cortisol as a predictor of treatment outcome.
|Depressive Disorder||Procedure: Right prefrontal lowfrequency ( 1 hz) rTMS. Procedure: Electroconvulsive therapy (ECT)||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to Electroconvulsive Therapy (ECT).An Open Randomized Noninferiority Trial.|
- The total 17-item score on the Hamilton Rating Scale for depression [ Time Frame: during 3 weeks of treatment and 4 week s after last treatment ]
- UKU-side effect score [ Time Frame: at baseline at day 10 during the treatment period, just after termination of treatment and after 4 weeks of follow-up ]
|Study Start Date:||May 2002|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Right frontal low frequency rTMS
Procedure: Right prefrontal lowfrequency ( 1 hz) rTMS.
Right prefrontal low frequency (1 hz) rTMS. 15 sessions with one daily session during 3 weeks (weekends excluded). Each session covering 2 x 60 minutes of stimulation separated with an intertrain interval of 3 minutes
Active Comparator: 2
electroconvulsive therapy (ECT). Right unilateral ECT 3 time a week in 3 weeks
Procedure: Electroconvulsive therapy (ECT)
9 ECT ( 3 each week) during 3 weeks
Previous clinical controlled trials indicate that repetitive transcranial magnetic stimulation (rTMS) of the prefrontal cortex may relieve antidepressant symptoms. Most of these studies have used high frequency stimulation of the left frontal cortex. A few investigations have found that right frontal low frequency rTMS, which constitute a more gentle stimulus design has an antidepressant effective at the same level. Compared to ECT rTMS has obvious advantages. The new method implies focal stimulation of the brain, is not inducing epileptic seizures and does not require anesthesia. In addition rTMS does not seem to induce cognitive disturbances. Few studies have compared the antidepressant effect of rTMS with that of ECT. The main outcome indicates that high frequency rTMS of the left frontal cortex has an antidepressant effect which is comparable to that of ECT in the treatment of non-psychotic patients. It is difficult to draw definite conclusions from these studies, first of all because of small and highly selected study populations. In addition different stimulus designs make most of the mentioned studies incomparable.
The aim of the present study is to compare the antidepressant effect of low frequency rTMS of the right dorsolateral prefrontal cortex with ECT in a hospitalized population of major depressed patients (ICD-10/DSM-IV) in a randomized open noninferiority study.
About fifty percent of depressed patients have shown to be associated with an increased plasma cortisol concentration and HPA-axis activity expressed in non-suppression of plasma cortisol in association with the dexamethasone (DX-test) suppression test. Some studies have shown that the presence or absence of normalization of the HPA-axis activity and the DX-test during antidepressant treatment may be a predictor of recurrence. Other studies have shown that the physiological increase in the concentration of saliva cortisol during the first half an hour after awakening in the morning is accentuated in depressed patients and constitute a more simple expression of the HPA-.axis activity and predictor of outcome than the the dx-test.
Therefore we want to investigate the value of the increase in the morning cortisol concentration during the first half an hour after awakening as a predictor of antidepressant effect and outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299403
|University hospital of Aarhus, Risskov|
|Aarhus, Risskov, Denmark, 8240|
|Principal Investigator:||Poul Erik Buchholtz Hansen, senior phys.||Aarhus University Hospital, Risskov, Denmark|