Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Devices - Transcranial Magnetic Stimulation

Treatment: Devices: Transcranial Magnetic Stimulation
Intervention code [1] 0 0
Treatment: Devices
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/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00470028
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00470028