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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
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Procedure: right temporal low frequency (1 hz) rTMS
Procedure: Sham-rTMS
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham. A Clinical Controlled, Randomized, Blinded Study.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: 2 Procedure: Sham-rTMS
The coil is angled 90 degrees away from the scalp

Detailed 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622947

Locations
Denmark
University Hospital of Aarhus, Risskov
Aarhus, Risskov, Denmark, 8240
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Poul Erik B Hansen, consultant University Hospital og Aarhus, Denmark
  More Information

Publications:
Responsible Party: Poul Erik Buchholtz Hansen, senior phys., study principal investigator, University Hospital of Aarhus, Risskov, Denmark
ClinicalTrials.gov Identifier: NCT00622947     History of Changes
Other Study ID Numbers: M-20070144
Study First Received: January 24, 2008
Last Updated: June 25, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
Depression
antidepressant effect
rTMS
sham
cognition
saliva cortisol
brain derived neurotropic factor

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014