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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham: A Clinical Controlled, Randomized, Blinded Study

Conditions
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Depressive Disorder

Intervention / Treatment
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* Procedure: right temporal low frequency (1 hz) rTMS
* Procedure: Sham-rTMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: repetitive transcranial magnetic stimulation<br>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. | Procedure: right temporal low frequency (1 hz) rTMS<br>* Right temporal low frequency (1 hz) rTMS.<br>* Other names: A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used.;|
| Sham Comparator: Placebo stimulation<br>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. | Procedure: Sham-rTMS<br>* The coil is angled 90 degrees away from the scalp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total 17-item score on the Hamilton scale for depression | semistructured interview scale. | 4 weeks of treatment and 4 weeks of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, antidepressant effect, rTMS, sham, cognition, saliva cortisol, brain derived neurotropic factor