The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to ECT
NCT ID: NCT00299403
Last Updated: 2008-07-02
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2002-05-31
2007-05-31
Brief Summary
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In the same study we investigate the value of saliva cortisol as a predictor of treatment outcome.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Right frontal low frequency rTMS
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
Arms: 2
2
electroconvulsive therapy (ECT). Right unilateral ECT 3 time a week in 3 weeks
Electroconvulsive therapy (ECT)
9 ECT ( 3 each week) during 3 weeks
Interventions
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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
Arms: 2
Electroconvulsive therapy (ECT)
9 ECT ( 3 each week) during 3 weeks
Eligibility Criteria
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Inclusion Criteria
* The patient should be candidate for ECT.
* Moderate or severely depressed/Major depressed (ICD-10/DSM-IV)
* A total score on the Hamilton (17-item) rating scale for depression of 20 or above, or a subscale score of 10 ore above.
* Right handed,
* Age 18-80 years
Exclusion Criteria
* Epilepsy
* Metal devices in operated into the brain or chest.
* The patient is wearing cardiac pacemaker.
* Medical illness associated with disturbed CNS function
* Pregnancy
* Serious suicidality
* Severe agitation or delirium
* Alcoholic or drug dependency
* The patients exposed to coercive measures
18 Years
80 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Aarhus University Hospital , Risskov. Denmark
Principal Investigators
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Poul Erik Buchholtz Hansen, senior phys.
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital, Risskov, Denmark
Locations
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University hospital of Aarhus, Risskov
Aarhus, Risskov, Denmark
Countries
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References
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Klein E, Kreinin I, Chistyakov A, Koren D, Mecz L, Marmur S, Ben-Shachar D, Feinsod M. Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression: a double-blind controlled study. Arch Gen Psychiatry. 1999 Apr;56(4):315-20. doi: 10.1001/archpsyc.56.4.315.
Hansen PE, Ravnkilde B, Videbech P, Clemmensen K, Sturlason R, Reiner M, Parner E, Rosenberg R, Vestergaard P. Low-frequency repetitive transcranial magnetic stimulation inferior to electroconvulsive therapy in treating depression. J ECT. 2011 Mar;27(1):26-32. doi: 10.1097/YCT.0b013e3181d77645.
Other Identifiers
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20010072
Identifier Type: -
Identifier Source: org_study_id