Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents
This is a study to assess the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed 13-18 year olds.
In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarizing neurons. No anesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell, 2005) and appears to be quite safe.
Minimal data of TMS use in adolescents psychiatric disorders. Data only existed in seven patients of the four that were depressed two showed improvement in their depression (Quintana, 2005). No sham-controlled studies have been conducted.
The investigators wish to assess this in a sham-controlled study of 30 adolescents. The investigators hypothesize that rTMS will have an antidepressant effect and produce no neuropsychological impairment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents|
- All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase.
- Montgomery-Asberg Depression Rating Scale (MADRS)
- Clinical Global Impressions Scale (CGI)
- All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
- Rey Auditory Verbal Learning Test (RAVLT)
- Digit span forwards and backwards and Digit symbols (WAIS)
- Tower of London
- Verbal Fluency
- Trail A, B
- Beck Depression Inventory
- Centre for Epidemiological Studies - Depression - Child (CES-DC) scale
|Study Start Date:||April 2005|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
The study has two phases: the sham-controlled phase and an open phase.
Participants are randomly assigned to an active or sham TMS condition.
Following the sham controlled period participants participants in the sham rTMS condition will be offered active rTMS. Participants will have the opportunity to receive up to 6 weeks of active rTMS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470028
|Australia, New South Wales|
|Greenwich, New South Wales, Australia, 2065|
|Black Institute Building, School of Psychiatry, University of New South Wales|
|Sydney, New South Wales, Australia, 2031|
|Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Colleen Loo, FRANZCP; MD||University of New South Wales|