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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00470028




Registration number
NCT00470028
Ethics application status
Date submitted
3/05/2007
Date registered
7/05/2007
Date last updated
20/01/2010

Titles & IDs
Public title
Transcranial Magnetic Stimulation: Treatment Trial for Depressed Adolescents
Scientific title
A Study of Transcranial Magnetic Stimulation (TMS) Treatment in Depressed Adolescents
Secondary ID [1] 0 0
04263
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Primary outcome [2] 0 0
Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [2] 0 0
Primary outcome [3] 0 0
Clinical Global Impressions Scale (CGI)
Timepoint [3] 0 0
Secondary outcome [1] 0 0
All measures at baseline, at the end of the 4 week blind phase and at end of treatment in the open phase.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Rey Auditory Verbal Learning Test (RAVLT)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Digit span forwards and backwards and Digit symbols (WAIS)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Tower of London
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Verbal Fluency
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Trail A, B
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Beck Depression Inventory
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Centre for Epidemiological Studies - Depression - Child (CES-DC) scale
Timepoint [8] 0 0

Eligibility
Key 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.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Northside Clinic - Greenwich
Recruitment hospital [2] 0 0
Black Institute Building, School of Psychiatry, University of New South Wales - Sydney
Recruitment hospital [3] 0 0
Alfred Psychiatry Research Centre, The Alfred and Monash University Department of Psychological Medicine, The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Greenwich
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, FRANZCP; MD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Loo C, McFarquhar T, Walter G. Transcranial magnet... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00470028