Clinical trial NCT00470028: Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents
Official title: A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Depression
Keywords: TMS
Treatment
Adolescents
Safety
Efficacy
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: Monash University
First posted: 2007-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
measure: Clinical Global Impressions Scale (CGI)
Secondary outcomes:
measure: All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
measure: Rey Auditory Verbal Learning Test (RAVLT)
measure: Digit span forwards and backwards and Digit symbols (WAIS)
measure: Tower of London
measure: Verbal Fluency
measure: Trail A, B
measure: Beck Depression Inventory
measure: Centre for Epidemiological Studies - Depression - Child (CES-DC) scale
Other outcomes:
Locations:
city: Greenwich
country: Australia
facility: Northside Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Black Institute Building, School of Psychiatry, University of New South Wales
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital
state: Victoria
Study officials:
affiliation: University of New South Wales
name: Colleen Loo, FRANZCP; MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.