Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

NCT ID: NCT00470028

Last Updated: 2010-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2009-11-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: collaborator

The University of New South Wales

OTHER

Sponsor Role: lead

Principal Investigators

Colleen Loo, FRANZCP; MD

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales

Locations

Northside Clinic

Greenwich, New South Wales, Australia

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

Sydney, New South Wales, Australia

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

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: RESULT

PMID: 16630205 (View on PubMed)

Other Identifiers

04263

Identifier Type: -

Identifier Source: org_study_id