None listed
Conditions
Brief summary
TDAY is a pilot open-label randomised control study comparing two different forms of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Major Depressive Disorder (MDD) in adolescents and young adults. Participants with MDD will be randomised to one of two rTMS treatment groups. In both groups a magnetic coil will be applied to L) side of the scalp, in which the coil generates an electrical impulse to the stimulate the underlying brain tissue, No anaesthetic is required. Group 1 will receive what is considered a standard 10Hz treatment protocol while Group 2 will receive a more novel, intensive intermittent thetaburst (iTBS) treatment protocol. Treatments will be administered Monday - Friday for 4 weeks. All participants will be engaged with their treating doctor for the duration of the trial, and will continue their current treatment regimen (i.e., either maintain a stable dose of antidepressant medication, or continue without antidepressant treatment). The primary outcome measures of safety and tolerability will be assessed continually across the study by monitoring adverse events and dropout rates. The secondary outcome measure (change in depression score) will be assessed at the end of week 2 and week 4, with a further assessment at week 8 to ascertain if any improvements have been maintained, and if some participants have a delayed response to treatment. The study hypothesis is that the acceptability and safety/tolerability of the more novel intensive iTBS treatment protocol (Group 2) will similar or greater than that of the standard rTMS treatment protocol (Group 1).
Interventions
Repetitive Transcranial Stimulation (rTMS) is a technique known to modulate brain cortical activity and has demonstrated efficacy in the treatment of treatment resistant depression. Participants in this rTMS based study will be randomised to one of two active treatment groups with one of the groups (1) receiving "standard" treatment while the other group (2) will receive intermittent Theta Burst Stimulation (iTBS) treatment (the intervention). Participants in the iTBS groups will receive treatm
Repetitive Transcranial Stimulation (rTMS) is a technique known to modulate brain cortical activity and has demonstrated efficacy in the treatment of treatment resistant depression. Participants in this rTMS based study will be randomised to one of two active treatment groups with one of the groups (1) receiving "standard" treatment while the other group (2) will receive intermittent Theta Burst Stimulation (iTBS) treatment (the intervention). Participants in the iTBS groups will receive treatment at the left side dorsolateral prefrontal cortex, a site approximately 7 cm above the left eyebrow. The treatment schedule for the iTBS group is outlined below: Group 2 (iTBS) – Participants will receive 2 iTBS treatments per day, on three weekdays (Mondays, Wednesdays, Fridays) for the first two weeks and on two weekdays per week (Tuesdays and Thursdays) for the last two weeks. They will receive the same total number of treatments (20) as Group 1. Each treatment lasts for just over 3 minutes and is comprised of 20 trains of stimulation. Each train contains a 50 Hz burst of 3 pulses delivered every 200msec (i.e. 5 Hz) for 2 seconds followed by an 8 second intertrain interval. There will be a minimum of 30 minutes between treatments on each treatment day. The total duration of each session will be approximately 45 minutes. Treatments will be administered by a Division 1 nurse with specialist rTMS training and experience. Treatment attendance will be recorded in a paper copy treatment record form.
Sponsors
Orygen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No
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
Outcome results
None listed