Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

Phase 1

Terminated

• Conditions: Depression

• Registration Number: NCT00470028
• Lead Sponsor: The University of New South Wales

Brief Summary

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.

Detailed Description

The study has two phases: the sham-controlled phase and an open phase.

Sham-controlled Phase

Participants are randomly assigned to an active or sham TMS condition.

Open Phase

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-07
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• DSM-IV Major Depressive Episode of no more then 3 years.
• Montgomery-Asberg Depression Rating Scale score of 20 or more.
• Aged between 13 and 18.
• May or may not be taking antidepressant medication.

Exclusion Criteria

• Patient (or family is patient is under 18)not able to give informed consent.
• Failure to respond to ECT in current or past episodes of depression.
• Significant other Axis 1 psychiatric disorders e.g. schizophrenia.
• In imminent physical or psychological danger and needs a rapid clinical response due to inanition, psychosis or high suicide risk.
• Drug or alcohol abuse currently or in the last month.
• History of neurological illness e.g. epilepsy; neurosurgical procedure
• Mental in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.
• Women of child-bearing age whom pregnancy cannot be ruled out.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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
Centre for Epidemiological Studies - Depression - Child (CES-DC) scale
Verbal Fluency
Trail A, B
Beck Depression Inventory

Trial Locations

Locations (3)

Northside Clinic; 🇦🇺 Greenwich, New South Wales, Australia

Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Black Institute Building, School of Psychiatry, University of New South Wales; 🇦🇺 Sydney, New South Wales, Australia