NCT07786714Recruiting
Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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 trials. Participants will complete clinical interviews and questionnaires, a cognitive battery, and computerized behavioral tasks; wear a Fitbit and use smartphone applications for at least two weeks before and throughout treatment; receive neuromodulation therapy or sham stimulation over five consecutive days; and attend follow-up visits at 1 week, 1 month, and 3 months after treatment.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 19 Aug 2026
- Start date
- Aug 2026
- Primary completion date
- Aug 2028
- Lead sponsor
- Douglas Mental Health University Institute
- Diseases
- Schizophrenia
- NCT number
- NCT07786714
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Aug 2026 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous rTMS treatment
Other illness
- History of electroconvulsive therapy (ECT) in the past 6 months
- Contraindications for TMS (e.g., metal implants in head/neck, seizure history, brain tumor/neurosurgery, severe cardiac disease)
- Documented history of significant intellectual disability
Other
- Pregnancy, lactation, or intrauterine device
- Substance use during the treatment week (cigarettes and cannabis excluded from this consideration)
Who the study is looking for
- 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
Age in the registry: 18 years to 34 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill Lab for Computational Psychiatry and Translation Coordinator of this site? Confirm its status | Verdun | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.