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Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis

RecruitingNAAges 18 Years - 34 YearsAllDouglas Mental Health University Institute
NCT07786714 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to learn whether an accelerated form of neuromodulation therapy is safe, feasible, and well tolerated in young people at clinical high risk for psychosis (CHR-P), and whether it is associated with changes in candidate biomarkers of treatment response. Participants will be randomly assigned to receive either active accelerated intermittent theta burst stimulation (iTBS) or sham stimulation to the left dorsolateral prefrontal cortex, delivered over five consecutive days. The study will look at whether this accelerated treatment approach is safe and feasible for people at clinical high risk for psychosis, whether depressive symptoms improve after treatment, and whether computerized behavioural tasks and passive digital monitoring (wearables, smartphone apps, and speech analysis) can detect treatment-related changes that may serve as biomarkers for future, larger

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📋 Eligibility rules (as published)
Inclusion Criteria: * Meets clinical CHR-P criteria, confirmed by the Structured Interview for Psychosis-Risk Syndromes (SIPS) * Clinical team confirms sufficient stability to participate * Able to provide informed consent Exclusion Criteria: * Pregnancy, lactation, or intrauterine device * History of electroconvulsive therapy (ECT) in the past 6 months * Substance use during the treatment week (cigarettes and cannabis excluded from this consideration) * Contraindications for TMS (e.g., metal implants in head/neck, seizure history, brain tumor/neurosurgery, severe cardiac disease) * Previous rTMS treatment * Documented history of significant intellectual disability
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What it tests

  • Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting)
  • Sham Comparator: Sham iTBS
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Where

1 site
McGill Lab for Computational Psychiatry and Translation
Verdun, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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