Transcranial Magnetic Stimulation: Treatment Trial for De... | NCT00470028

Studies
Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents

NCT00470028

Sponsor

The University of New South Wales

Status

Terminated

Last Update Posted

Jan 20, 2010Estimated

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment.

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

May 3, 2007

First Submission Date that Met QC Criteria

May 3, 2007

First Posted Date

May 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2010

Last Update Posted Date

Jan 20, 2010Estimated

Name	Class
University of Sydney	OTHER
Monash University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Magnetic Stimulation	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.
Montgomery-Asberg Depression Rating Scale (MADRS)
Clinical Global Impressions Scale (CGI)

Secondary Outcomes

Measure	Description	Time Frame
All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
Rey Auditory Verbal Learning Test (RAVLT)
Digit span forwards and backwards and Digit symbols (WAIS)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colleen Loo, FRANZCP; MD	University of New South Wales	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northside Clinic		Greenwich	New South Wales	2065	Australia
Black Institute Building, School of Psychiatry, University of New South Wales

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16630205	Result	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics