Trials / Terminated

TerminatedNCT00470028

Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

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

Status: Terminated
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 30 (estimated)

Sponsor: The University of New South Wales · Academic / Other
Sex: All
Age: 13 Years – 18 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation

Timeline

Start date: 2005-04-01
Primary completion: 2009-11-01
Completion: 2009-11-01
First posted: 2007-05-07
Last updated: 2010-01-20

Locations

3 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT00470028. Inclusion in this directory is not an endorsement.