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Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

Primary Purpose

Depression

Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring TMS, Treatment, Adolescents, Safety, Efficacy

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northside Clinic
  • Black Institute Building, School of Psychiatry, University of New South Wales
  • Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital

Outcomes

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

Full Information

First Posted
May 3, 2007
Last Updated
January 19, 2010
Sponsor
The University of New South Wales
Collaborators
University of Sydney, Monash University
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1. Study Identification

Unique Protocol Identification Number
NCT00470028
Brief Title
Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents
Official Title
A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment.
Study Start Date
April 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of New South Wales
Collaborators
University of Sydney, Monash University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
TMS, Treatment, Adolescents, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
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.
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Title
Clinical Global Impressions Scale (CGI)
Secondary Outcome Measure Information:
Title
All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
Title
Rey Auditory Verbal Learning Test (RAVLT)
Title
Digit span forwards and backwards and Digit symbols (WAIS)
Title
Tower of London
Title
Verbal Fluency
Title
Trail A, B
Title
Beck Depression Inventory
Title
Centre for Epidemiological Studies - Depression - Child (CES-DC) scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, FRANZCP; MD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northside Clinic
City
Greenwich
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Black Institute Building, School of Psychiatry, University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16630205
Citation
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.
Results Reference
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Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

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