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Transcranial Magnetic Stimulation (TMS) as a Treatment/Intervention for Depression in Adolescents and Young adults

Not Applicable
Suspended
Conditions
Depression
Mental Health - Depression
Registration Number
ACTRN12621001186842
Lead Sponsor
Orygen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
All
Target Recruitment
40
Inclusion Criteria

A participant will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
•Aged 15 – 25years old
•Capacity to consent
•Current major depressive episode as determined by psychiatrist/ psychiatry trainee (persons with BPAD in a depressive phase can be included)
•A QIDS-C of > 10 (moderate to severe depression)
•Treatment resistance defined as a failure to respond to first-line treatment with structured psychotherapy or antidepressant medication
•If taking psychotropic medication regime, on a stable dose in the four weeks prior to screening

Exclusion Criteria

Participants who meet ANY of the following criteria will not be eligible for participation in this study.
•History of seizure disorder or any condition leading to an increased risk of seizure
•Significant neurological disorder or brain trauma
•Presence of internal metal objects in the head, either implanted or result of shrapnel injury, that would be considered unsafe for MRI (dental work is not an exclusion)
•Any implanted medical devices with electronic components (e.g.: pacemaker, neural stimulator)
•Current severe or uncontrolled substance use as assessed by study psychiatrist interview at screening
•Any unstable or poorly managed significant medical condition
•Females who are pregnant or currently breastfeeding, or who are not using effective contraception.
•Participation in any other clinical intervention trial from baseline to the Week 8 follow-up
•Comorbid psychotic/delusional disorders or any psychiatric disorder that would prevent patient from attending treatment schedule
•Severe behavioural disturbances such that they would be unable to comply with the requirements of informed consent or comply with the study protocol

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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