Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

The University of New South Wales

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Depression

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00470028

04263

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

13 to 18 years old

Volunteers

No 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.