An Evaluation of Repetitive Transcranial Magnetic Stimulation as a Treatment for Depression in Adolescent Patients.

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.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000907640

Enrollment

Registered

2014-08-26

Start date

2017-01-19

Completion date

2017-01-19

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

13 Years to 18 Years

Healthy volunteers

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.

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.

Outcome results