Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299403
Status:
COMPLETED
Last Update Posted:
2008-07-02
First Post:
2006-03-03
Brief Title:
The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation rTMSCompared to ECT
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation rTMSCompared to Electroconvulsive Therapy ECTAn Open Randomized Noninferiority Trial
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
In the same study we investigate the value of saliva cortisol as a predictor of treatment outcome
Detailed Description:
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-10DSM-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
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-10DSM-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None