The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to ECT
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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-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.
    

Intervention name(s): Right prefrontal lowfrequency ( 1 hz) rTMS.; Electroconvulsive therapy (ECT)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; 9 ECT ( 3 each week) during 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive disorder,; Antidepressant effect,; rTMS,; ECT,; cognition,; Saliva cortisol; noninferiority trial