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

University of Aarhus

Status: Terminated

Conditions: Depressive Disorder

Treatments: Procedure: right temporal low frequency (1 hz) rTMS; Procedure: Sham-rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT00622947

M-20070144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

repetitive transcranial magnetic stimulation

Active Comparator group

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.

Treatment:

Procedure: right temporal low frequency (1 hz) rTMS

Placebo stimulation

Sham Comparator group

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.

Treatment:

Procedure: Sham-rTMS