NCT00470028

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_1 depression

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

November 1, 2009

Enrollment Period

4.6 years

First QC Date

May 3, 2007

Last Update Submit

January 19, 2010

Conditions

Depression

Keywords

TMSTreatmentAdolescentsSafetyEfficacy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

Transcranial Magnetic StimulationDEVICE

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northside Clinic

Greenwich, New South Wales, 2065, Australia

Location

Black Institute Building, School of Psychiatry, University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

  • 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.

    PMID: 16630205RESULT

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Colleen Loo, FRANZCP; MD

    University of New South Wales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

April 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 20, 2010

Record last verified: 2009-11

Locations

AU(3)