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

June 30, 2008 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Risskov
      • Aarhus, Risskov, Denmark, 8240
        • University hospital of Aarhus, Risskov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during 3 weeks of treatment and 4 week s after last treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at baseline at day 10 during the treatment period, just after termination of treatment and after 4 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Poul Erik Buchholtz Hansen, senior phys., Aarhus University Hospital, Risskov, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

July 2, 2008

Last Update Submitted That Met QC Criteria

June 30, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20010072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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