Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study (NCT03680781) | Clinical Trial Compass
CompletedNot Applicable
Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
United States40 participantsStarted 2018-04-13
Plain-language summary
This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, 18 to 75 years of age.
* Able to provide informed consent.
* Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE).
* prior exposure to rTMS
* Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method.
* Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration.
* Participants are required to have a stable psychiatrist for the duration of study enrollment.
Exclusion Criteria:
* History of MI, CABG, CHF, or other cardiac history
* Any neurological conditions
* History of epilepsy
* OCD
* Independent sleep disorder
* Autism Spectrum Disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hamilton Depression Rating Scale 21-Item Score
Timeframe: Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5)