The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham
NCT ID: NCT00622947
Last Updated: 2019-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2008-02-29
2010-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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repetitive transcranial magnetic stimulation
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.
right temporal low frequency (1 hz) rTMS
Right temporal low frequency (1 hz) rTMS.
Placebo stimulation
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.
Sham-rTMS
The coil is angled 90 degrees away from the scalp
Interventions
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right temporal low frequency (1 hz) rTMS
Right temporal low frequency (1 hz) rTMS.
Sham-rTMS
The coil is angled 90 degrees away from the scalp
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Poul Erik B Hansen, consultant
Role: PRINCIPAL_INVESTIGATOR
University Hospital og Aarhus, Denmark
Locations
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University Hospital of Aarhus, Risskov
Aarhus, Risskov, Denmark
Countries
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References
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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.
Other Identifiers
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M-20070144
Identifier Type: -
Identifier Source: org_study_id
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