Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

A Study of Transcranial Magnetic Stimulation (TMS) Treatment in 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 Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Greenwich, New South Wales, Australia, 2065
      • Northside Clinic
    • Sydney, New South Wales, Australia, 2031
      • Black Institute Building, School of Psychiatry, University of New South Wales
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Clinical Global Impressions Scale (CGI)

Secondary Outcome Measures

Outcome Measure
Beck Depression Inventory
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
Centre for Epidemiological Studies - Depression - Child (CES-DC) scale

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: Monash University; University of Sydney
• Investigators: Principal Investigator: Colleen Loo, FRANZCP; MD, University of New South Wales

Publications and helpful links

General Publications

• Loo C, McFarquhar T, Walter G. Transcranial magnetic stimulation in adolescent depression. Australas Psychiatry. 2006 Mar;14(1):81-5. doi: 10.1080/j.1440-1665.2006.02251.x.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: May 3, 2007
• First Submitted That Met QC Criteria: May 3, 2007
• First Posted (Estimate): May 7, 2007

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Adolescents; Treatment; Safety; Efficacy; TMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 04263