Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

Depression Clinical Trial

Official title:

A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00470028
• Other study ID #: 04263
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 3, 2007
• Last updated: January 19, 2010
• Start date: April 2005
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
Australia	Northside Clinic	Greenwich	New South Wales
Australia	Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital	Melbourne	Victoria
Australia	Black Institute Building, School of Psychiatry, University of New South Wales	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
The University of New South Wales	Monash University, University of Sydney

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Loo C, McFarquhar T, Walter G. Transcranial magnetic stimulation in adolescent depression. Australas Psychiatry. 2006 Mar;14(1):81-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)
Primary	Clinical Global Impressions Scale (CGI)
Secondary	All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
Secondary	Rey Auditory Verbal Learning Test (RAVLT)
Secondary	Digit span forwards and backwards and Digit symbols (WAIS)
Secondary	Tower of London
Secondary	Verbal Fluency
Secondary	Trail A, B
Secondary	Beck Depression Inventory
Secondary	Centre for Epidemiological Studies - Depression - Child (CES-DC) scale