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The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to ECT

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00299403
First received: March 3, 2006
Last updated: June 30, 2008
Last verified: June 2008

March 3, 2006
June 30, 2008
May 2002
May 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The total (17-item)score on the Hamilton rating scale for depression
Complete list of historical versions of study NCT00299403 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
  • Cognitive function evaluated by psychological testing at baseline and after 15 treatment sessions of rTMS or 9 ECT.
  • Saliva cortisol concentration
Not Provided
Not Provided
 
The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to ECT
The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to Electroconvulsive Therapy (ECT).An Open Randomized Noninferiority Trial.

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressive Disorder
  • 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

    Arms: 2

  • Procedure: Electroconvulsive therapy (ECT)
    9 ECT ( 3 each week) during 3 weeks
  • Active Comparator: 1
    Right frontal low frequency rTMS
    Intervention: Procedure: Right prefrontal lowfrequency ( 1 hz) rTMS.
  • Active Comparator: 2
    electroconvulsive therapy (ECT). Right unilateral ECT 3 time a week in 3 weeks
    Intervention: Procedure: Electroconvulsive therapy (ECT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Admission to Psychiatric Hospital in Aarhus.
  • 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:

  • Organic brain disease
  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00299403
20010072
No
Poul Erik Buchholtz Hansen, Aarhus University Hospital , Risskov. Denmark
University of Aarhus
Not Provided
Principal Investigator: Poul Erik Buchholtz Hansen, senior phys. Aarhus University Hospital, Risskov, Denmark
University of Aarhus
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP