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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299403
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : July 2, 2008
Information provided by:
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Procedure: Right prefrontal lowfrequency ( 1 hz) rTMS. Procedure: Electroconvulsive therapy (ECT) Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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.
Study Start Date : May 2002
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arm Intervention/treatment
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

Arms: 2

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299403

University hospital of Aarhus, Risskov
Aarhus, Risskov, Denmark, 8240
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Poul Erik Buchholtz Hansen, senior phys. Aarhus University Hospital, Risskov, Denmark

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Poul Erik Buchholtz Hansen, Aarhus University Hospital , Risskov. Denmark Identifier: NCT00299403     History of Changes
Other Study ID Numbers: 20010072
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: June 2008

Keywords provided by University of Aarhus:
Depressive disorder,
Antidepressant effect,
Saliva cortisol
noninferiority trial

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs