Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

This study has been terminated.
(Low recruitment.)
Sponsor:
Collaborators:
University of Sydney
Monash University
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00470028
First received: May 3, 2007
Last updated: January 19, 2010
Last verified: November 2009
  Purpose

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 Intervention Phase
Depression
Device: Transcranial Magnetic Stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 30
Study Start Date: April 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00470028

Locations
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
Investigators
Principal Investigator: Colleen Loo, FRANZCP; MD University of New South Wales
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00470028     History of Changes
Other Study ID Numbers: 04263
Study First Received: May 3, 2007
Last Updated: January 19, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:
TMS
Treatment
Adolescents
Safety
Efficacy

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 23, 2014