Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000907640
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
26/08/2014
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Date results information initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of Repetitive Transcranial Magnetic Stimulation as a Treatment for Depression in Adolescent Patients.
Scientific title
Do adolescents with major depressive disorder (MDD) who receive left-sided, high frequency transcranial magnetic stimulation (TMS) experience reduction in depressive symptoms more than those adolescents with MDD who are given right sided TMS.
Secondary ID [1] 285037 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 292546 0
Anxiety 292834 0
Condition category
Condition code
Mental Health 292854 292854 0 0
Depression
Mental Health 293134 293134 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescent patients will receive 20 daily sessions over four weeks of left-sided, high frequency (10 Htz) repetitive transcranial magnetic stimulation over one month. Repetitive transcranial magnetic stimulation will be administered using MagPro x 100, magnetic stimulator figure of eight coil, coolant-cooled coil. The duration of each treatment session will be 30 minutes.
Intervention code [1] 289868 0
Treatment: Devices
Comparator / control treatment
A comparison treatment will be right-sided, low frequency (1 Htz) repetitive transcranial magnetic stimulation given over four weeks using MagPro x 100, magnetic stimulator, coolant-cooled coil. The treatment will be applied by daily sessions over one month. The total number of treatment administered will be 20 x 30 minute sessions.
Control group
Active

Outcomes
Primary outcome [1] 292897 0
Children's Depression Rating Scale Revised (CDRS-R)
Timepoint [1] 292897 0
At the end of treatment (i.e.at 4 weeks following the start of treatment).
Primary outcome [2] 292898 0
Children's Depression Rating Scale Revised (CDRS-R)
Timepoint [2] 292898 0
One month post the completion of treatment (i.e.at 8 weeks following the start of treatment).
Secondary outcome [1] 309886 0
Mood and Feelings Questionnaire (MFQ)
Timepoint [1] 309886 0
Immediately following the end of treatment (at 4 weeks after starting treatment), and then again one month post the completion of treatment (i.e. at 8 weeks following the start of treatment).
Secondary outcome [2] 309887 0
Screen for Child Anxiety and Related Disorders (SCARED)
Timepoint [2] 309887 0
Immediately following the end of treatment (at 4 weeks after starting treatment), and then again one month post the completion of treatment (i.e. at 8 weeks following the start of treatment).
Secondary outcome [3] 309888 0
Clinical Global Impression (CGI)
Timepoint [3] 309888 0
Immediately following the end of treatment (at 4 weeks after starting treatment), and then again one month post the completion of treatment (i.e. at 8 weeks following the start of treatment).

Eligibility
Key inclusion criteria
adolescents with a current DSM-IV diagnosis of Major Depressive Disorder diagnosed by a trained clinician using the Kiddie-SADS-Present and Lifetime Version and scores above 45 on the Children's Depression Rating Scale Revised.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient who have had Electroconvulsive Therapy (ECT) in the current episode of depression are excluded. Diagnoses of schizophrenia, bipolar affective disorder, intellectual disability, restrictive eating disorder, autism, drug dependence, epilepsy, any neurosurgical procedure severe medical illness (such as heart disease), metal in the cranium, pacemaker, cochlear implant, patients who have medication pump or other electronic device, or pregnant women are all excluded from this study.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
time series regression

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/06/2014
Actual
19/01/2017
Date of last participant enrolment
Anticipated
Actual
19/01/2017
Date of last data collection
Anticipated
Actual
29/06/2017
Sample size
Target
40
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2832 0
Dandenong Hospital - Dandenong
Recruitment hospital [2] 2833 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 8523 0
3175 - Dandenong
Recruitment postcode(s) [2] 8636 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 289752 0
Commercial sector/Industry
Name [1] 289752 0
Woolworths Supermarkets
Country [1] 289752 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road, Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 288443 0
Hospital
Name [1] 288443 0
Monash Medical Centre
Address [1] 288443 0
246 Clayton Road, Clayton, Victoria 3168
Country [1] 288443 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291486 0
Monash Health HREC
Ethics committee address [1] 291486 0
246 Clayton Road, Clayton, Victoria, 3168
Ethics committee country [1] 291486 0
Australia
Date submitted for ethics approval [1] 291486 0
Approval date [1] 291486 0
09/01/2014
Ethics approval number [1] 291486 0
13419B

Summary
Brief summary
Depressive disorders in adolescents are common, disabling and at times life-threatening conditions. Safe and effective biological treatments are few. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive intervention, in which a potent and brief magnetic pulse is generated by an external coil applied to the scalp. rTMS has a remission rate when used in depressed adults of 30% to 40%. The Food and Drug Administration (FDA) approved rTMS for use in depressed adults in 2008.

While rTMS has been shown to be safe and effective in adults, there is very limited information about the safety or efficacy of rTMS in depressed adolescents.

This is a pilot study to explore the safety and effectiveness in the use of rTMS for adolescents with Major Depressive Disorder. In the proposed study, we will investigate the relative efficacy of low frequency right-sided rTMS compared with high frequency left-sided rTMS for depressed adolescents. It is hypothesized that left-sided high frequency TMS and right-sided low-frequency TMS will be of similar therapeutic benefit in the treatment of adolescent patients with Major Depressive Disorder. It is believed that there will be minimal side effects with overall benefits in depressive and anxiety symptoms.

The study will involve 40 adolescent participants with MDD diagnosed by a trained clinician. The 40 participants will be randomly allocated to one of either low frequency right-sided rTMS (20 subjects) or high frequency left-sided rTMS (20 subjects). Both groups of subjects will receive daily treatment for 5 days per week, over 4 weeks (20 sessions) with the respective treatment.

Following initial treatment, responders to this will be followed up following treatment and one month after the end of treatment with Children Rating Scale Revised.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50134 0
A/Prof Michael S.Gordon
Address 50134 0
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 50134 0
Australia
Phone 50134 0
+61 3 95941300
Fax 50134 0
+61 3 95946333
Email 50134 0
[email protected]
Contact person for public queries
Name 50135 0
A/Prof Michael S.Gordon
Address 50135 0
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 50135 0
Australia
Phone 50135 0
+61 3 95941300
Fax 50135 0
+61 3 95946333
Email 50135 0
[email protected]
Contact person for scientific queries
Name 50136 0
A/Prof Michael S.Gordon
Address 50136 0
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 50136 0
Australia
Phone 50136 0
+61 3 95941300
Fax 50136 0
+61 3 95946333
Email 50136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not provided the participants with this in the information they were given to provide consent to the study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10656Study protocol  [email protected]
10657Informed consent form  [email protected]
10658Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcceptability, safety and tolerability of antidepressant repetitive transcranial magnetic stimulation for adolescents: A mixed-methods investigation.2022https://dx.doi.org/10.1016/j.jad.2022.04.057
N.B. These documents automatically identified may not have been verified by the study sponsor.