Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00470028
Recruitment Status : Terminated (Low recruitment.)
First Posted : May 7, 2007
Last Update Posted : January 20, 2010
University of Sydney
Monash University
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Depression Device: Transcranial Magnetic Stimulation Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents
Study Start Date : April 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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.
  2. Montgomery-Asberg Depression Rating Scale (MADRS)
  3. Clinical Global Impressions Scale (CGI)

Secondary Outcome Measures :
  1. All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
  2. Rey Auditory Verbal Learning Test (RAVLT)
  3. Digit span forwards and backwards and Digit symbols (WAIS)
  4. Tower of London
  5. Verbal Fluency
  6. Trail A, B
  7. Beck Depression Inventory
  8. Centre for Epidemiological Studies - Depression - Child (CES-DC) scale

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00470028

Australia, New South Wales
Northside Clinic
Greenwich, New South Wales, Australia, 2065
Black Institute Building, School of Psychiatry, University of New South Wales
Sydney, New South Wales, Australia, 2031
Australia, Victoria
Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The University of New South Wales
University of Sydney
Monash University
Principal Investigator: Colleen Loo, FRANZCP; MD University of New South Wales

Publications of Results: Identifier: NCT00470028     History of Changes
Other Study ID Numbers: 04263
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: November 2009

Keywords provided by The University of New South Wales: