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The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham

Primary Purpose

Depressive Disorder

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
right temporal low frequency (1 hz) rTMS
Sham-rTMS
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 Depression, antidepressant effect, rTMS, sham, cognition, saliva cortisol, brain derived neurotropic factor

Eligibility Criteria

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

Inclusion Criteria:

  • Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area.
  • Moderate - severe depression according to ICD-10/ DSM-IVR
  • Age 18-80 years
  • Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9
  • Right handed

Exclusion Criteria:

  • Organic brain disease
  • Epilepsy in growing age
  • Metallic objects as the result of a chest or Brain surgery
  • Cardiac pacemakers
  • Somatic diseases associated with brain dysfunction
  • Pregnancy
  • Suicide risk of severe degree
  • Severe agitation or delirium
  • Alcohol and drug dependency
  • Ongoing Electroconvulsive treatment

Sites / Locations

  • University Hospital of Aarhus, Risskov

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

repetitive transcranial magnetic stimulation

Placebo stimulation

Arm Description

Low frequency ( 1 HZ) rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.

Sham- rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.

Outcomes

Primary Outcome Measures

The total 17-item score on the Hamilton scale for depression
semistructured interview scale.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2008
Last Updated
March 14, 2019
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00622947
Brief Title
The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham
Official Title
The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham: A Clinical Controlled, Randomized, Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Too few patients included
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 low frequency rTMS applied over the right temporal cortex with sham stimulation.
Detailed Description
TMS complies focal stimulation of the brain through a time varying magnetic field. Clinical controlled trials indicate that rTMS of the dorsolateral prefrontal cortex may have an antidepressant effect and no serious side effects. Several clinical controlled studies investigating the antidepressant effect of low as well as high frequency rTMS of the right and left prefrontal cortex have been carried out with varying results.Research on the issue suffer from small and selected study populations.There is a need for additional clinical controlled studies on larger samples and methodological investigations to clarify what is the optimal stimulus design for the treatment of depressed patients. Recent research indicates that Depression is associated with an increased metabolic activity of subcortical areas especially the right hippocampus of the brain. Remission of depression symptoms is associated with normalisation of the described subcortical hyperactivity. Low frequency rTMS has shown to be associated with sustained reduction in neuronal activity. There may be an association between the activity decreasing effect of low frequency rTMS and reduction in psychiatric symptoms. The investigators want to test the hypothesis that low frequency rTMS of the right temporal subcortical areas (Hippocampus and and the parahippocampal part of CNS) may perform an antidepressant effect by normalizing the described hyperactivity of the subcortical areas in depressed patients. In addition the investigators want to test whether blood concentration of Brain Derived Neurotropic Factor( BDNF), the BDNF-genotype and saliva cortisol may be of predictive value in depressed patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Depression, antidepressant effect, rTMS, sham, cognition, saliva cortisol, brain derived neurotropic factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
Low frequency ( 1 HZ) rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.
Arm Title
Placebo stimulation
Arm Type
Sham Comparator
Arm Description
Sham- rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.
Intervention Type
Procedure
Intervention Name(s)
right temporal low frequency (1 hz) rTMS
Other Intervention Name(s)
A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used.
Intervention Description
Right temporal low frequency (1 hz) rTMS.
Intervention Type
Procedure
Intervention Name(s)
Sham-rTMS
Intervention Description
The coil is angled 90 degrees away from the scalp
Primary Outcome Measure Information:
Title
The total 17-item score on the Hamilton scale for depression
Description
semistructured interview scale.
Time Frame
4 weeks of treatment and 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: Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area. Moderate - severe depression according to ICD-10/ DSM-IVR Age 18-80 years Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9 Right handed Exclusion Criteria: Organic brain disease Epilepsy in growing age Metallic objects as the result of a chest or Brain surgery Cardiac pacemakers Somatic diseases associated with brain dysfunction Pregnancy Suicide risk of severe degree Severe agitation or delirium Alcohol and drug dependency Ongoing Electroconvulsive treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poul Erik B Hansen, consultant
Organizational Affiliation
University Hospital og Aarhus, 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
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The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham

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