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

This study has been terminated.
(to few included patients)
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00622947
First received: January 24, 2008
Last updated: June 25, 2010
Last verified: June 2010

January 24, 2008
June 25, 2010
February 2008
February 2010   (final data collection date for primary outcome measure)
The total 17-item score on the Hamilton scale for depression [ Time Frame: 4 weeks of treatment and 4 weeks of follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622947 on ClinicalTrials.gov Archive Site
The outcome of the UKU side effect scale [ Time Frame: During 4 weeks of treatment and 4 weeks of follow-up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham
The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham. A Clinical Controlled, Randomized, Blinded Study.

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.

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.

We 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 we 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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Depressive Disorder
  • Procedure: right temporal low frequency (1 hz) rTMS
    A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used. Low frequency rTMS at 1 Hz of right temporal cortex. Each session covering 2 trains of 60 sec. and 180 sec intertrain interval.
  • Procedure: Sham-rTMS
    The coil is angled 90 degrees away from the scalp
  • Active Comparator: 1
    A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular is used. Low frequency rTMS at 1 Hz of right temporal cortex. Each session covering 2 trains of 60 sec. and 180 sec intertrain interval.
    Intervention: Procedure: right temporal low frequency (1 hz) rTMS
  • Placebo Comparator: 2
    Intervention: Procedure: Sham-rTMS
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00622947
M-20070144
No
Poul Erik Buchholtz Hansen, senior phys., study principal investigator, University Hospital of Aarhus, Risskov, Denmark
University of Aarhus
Not Provided
Principal Investigator: Poul Erik B Hansen, consultant University Hospital og Aarhus, Denmark
University of Aarhus
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP