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

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Right prefrontal lowfrequency ( 1 hz) rTMS.
Electroconvulsive therapy (ECT)
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Depressive disorder,, Antidepressant effect,, rTMS,, ECT,, cognition,, Saliva cortisol, noninferiority trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital of Aarhus, Risskov

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Right frontal low frequency rTMS

electroconvulsive therapy (ECT). Right unilateral ECT 3 time a week in 3 weeks

Outcomes

Primary Outcome Measures

The total 17-item score on the Hamilton Rating Scale for depression

Secondary Outcome Measures

UKU-side effect score

Full Information

First Posted
March 3, 2006
Last Updated
June 30, 2008
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00299403
Brief Title
The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to ECT
Official Title
The Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)Compared to Electroconvulsive Therapy (ECT).An Open Randomized Noninferiority Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Depressive disorder,, Antidepressant effect,, rTMS,, ECT,, cognition,, Saliva cortisol, noninferiority trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Right frontal low frequency rTMS
Arm Title
2
Arm Type
Active Comparator
Arm Description
electroconvulsive therapy (ECT). Right unilateral ECT 3 time a week in 3 weeks
Intervention Type
Procedure
Intervention Name(s)
Right prefrontal lowfrequency ( 1 hz) rTMS.
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Electroconvulsive therapy (ECT)
Intervention Description
9 ECT ( 3 each week) during 3 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poul Erik Buchholtz Hansen, senior phys.
Organizational Affiliation
Aarhus University Hospital, Risskov, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Aarhus, Risskov
City
Aarhus
State/Province
Risskov
ZIP/Postal Code
8240
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
10197825
Citation
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.
Results Reference
background
PubMed Identifier
20351570
Citation
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.
Results Reference
derived

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

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