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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00622947
• Other study ID #: M-20070144
• Status: Terminated
• Phase: N/A
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Denmark	University Hospital of Aarhus, Risskov	Aarhus	Risskov

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total 17-item score on the Hamilton scale for depression	semistructured interview scale.	4 weeks of treatment and 4 weeks of follow-up