ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Major Depressive Disorder

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

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]

Children's Depression Rating Scale Revised (CDRS-R)

Timepoint [1]

At the end of treatment (i.e.at 4 weeks following the start of treatment).

Primary outcome [2]

Children's Depression Rating Scale Revised (CDRS-R)

Timepoint [2]

One month post the completion of treatment (i.e.at 8 weeks following the start of treatment).

Secondary outcome [1]

Mood and Feelings Questionnaire (MFQ)

Timepoint [1]

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]

Screen for Child Anxiety and Related Disorders (SCARED)

Timepoint [2]

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]

Clinical Global Impression (CGI)

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Dandenong Hospital - Dandenong

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3175 - Dandenong

Recruitment postcode(s) [2]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Woolworths Supermarkets

Address [1]

522 Wellington Road, Mulgrave, Victoria 3170

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

246 Clayton Road, Clayton, Victoria 3168

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Monash Medical Centre

Address [1]

246 Clayton Road, Clayton, Victoria 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

246 Clayton Road, Clayton, Victoria, 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/01/2014

Ethics approval number [1]

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

A/Prof Michael S.Gordon

Address

Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168

Country

Australia

Phone

+61 3 95941300

Fax

+61 3 95946333

[email protected]

Contact person for public queries

Name

Michael S.Gordon

Address

Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168

Country

Australia

Phone

+61 3 95941300

Fax

+61 3 95946333

[email protected]

Contact person for scientific queries

Name

Michael S.Gordon

Address

Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168

Country

Australia

Phone

+61 3 95941300

Fax

+61 3 95946333

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
10656	Study protocol	[email protected]
10657	Informed consent form	[email protected]
10658	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Acceptability, safety and tolerability of antidepressant repetitive transcranial magnetic stimulation for adolescents: A mixed-methods investigation.	2022	https://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.

Trial Review

Documents added manually

Documents added automatically