An interventional study of Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting) and Sham Comparator: Sham iTBS in Clinical High Risk for Psychosis (CHR), Psychotic Disorders and Prodromal Symptoms, sponsored by Douglas Mental Health University Institute. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 34 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Douglas Mental Health University Institute · Not applicable, Interventional, and Treatment
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.
There is currently no clinically validated treatment that reduces the risk of psychosis onset or mitigates the severity of a first psychotic episode in individuals at clinical high risk for psychosis (CHR-P). CHR-P is associated with attenuated psychotic symptoms, functional decline, and high rates of affective symptoms, including a comorbid mood disorder prevalence of 40% or higher. Repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (LDLPFC) is an established treatment for depression and is increasingly supported for negative symptoms in psychotic disorders, making it a promising low-burden candidate for early intervention in CHR-P.
This pilot study evaluates an accelerated intermittent theta burst stimulation (iTBS) protocol, delivered over five consecutive days, in individuals at CHR-P (SIPS-confirmed, aged 18-34). Forty participants will be randomized 1:1 to active accelerated iTBS or sham stimulation to the LDLPFC, using standard scalp-based (BEAM-F3) targeting rather than MRI-guided neuronavigation, reflecting the pilot nature and funding constraints of this early-phase study.
Given the variable incidence of and long latency to psychosis onset in the CHR-P population, this study also incorporates a battery of neurocomputational tasks (analyzed using Hierarchical Gaussian Filter modeling) and a multimodal digital phenotyping framework (wearables, smartphone-based passive sensing, facial/vocal affect analysis, and structured speech analysis) to assess candidate biomarkers of treatment response.
Primary outcomes are the safety, feasibility, and tolerability of the accelerated protocol in this population. Secondary outcomes include the sensitivity of neurocomputational biomarkers to treatment and change in depressive symptoms. Exploratory outcomes include treatment-related change across multiple domains of real-world functioning captured through digital phenotyping. This study is not designed to establish definitive treatment efficacy but to inform the design of future, adequately powered trials.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Douglas Mental Health University Institute is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive active accelerated iTBS over five consecutive days (up to 10 sessions/day, up to 50 sessions total) targeting the left dorsolateral prefrontal cortex (LDLPFC) using standard BEAM-F3 scalp-based coordinates.
Device: Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting)
Participants receive sham stimulation over five consecutive days, using the same device, coil, session structure, and schedule as the active arm, without delivering therapeutic cortical stimulation.
Device: Sham Comparator: Sham iTBS
Active iTBS is delivered using a MagVenture MagPro X100 stimulator with Cool-B65 A/P coil, targeting the LDLPFC at 110% of resting motor threshold (motor threshold determined via the PEST algorithm). Each session consists of 60 trains of 10 bursts of three pulses at 50 Hz, delivered every 200 ms, with an 8-second intertrain interval (1,800 pulses/session; up to 18,000 pulses/day; 90,000 pulses total over 5 days). The number of daily sessions is reviewed after every five participants and may be reduced from 10 to 8, or to 6, if needed; missed sessions are made up during the following week to preserve total pulse dose.
Sham iTBS is delivered using the same MagVenture Cool B65 A/P coil (device-integrated sham mode), with identical coil placement, session structure, and treatment schedule as the active arm.
Treatment Initiation Rate
Proportion of consenting participants who begin the treatment protocol (receive at least one stimulation session).
Time frame: Through end of treatment week (Day 5)
Treatment Acceptability Rate
Proportion of approached, eligible individuals who consent to participate in the study.
Time frame: Through study completion, an average of 18 months.
Treatment Adherence
Number of treatment sessions completed per participant, out of the planned schedule (up to 10 sessions/day over 5 days).
Time frame: Through end of treatment week (Day 5)
Treatment Completion Rate
Proportion of participants who initiate treatment and complete the full course; expected completion rate of approximately 80%, based on prior work at the study site.
Time frame: Through end of treatment week (Day 5)
Incidence of Adverse and Serious Adverse Events
Rate of treatment-related adverse events (e.g., scalp pain, headache, fatigue, symptom worsening) and serious adverse events (e.g., seizure, hospitalization, emergent suicidality), assessed via daily clinical ratings and structured interviews.
Time frame: Baseline through 3-month follow-up
Qualitative Treatment Experience
Themes related to participant experience of tolerability and treatment burden, derived from a structured end-of-treatment qualitative interview and analyzed using inductive thematic analysis.
Time frame: End of treatment (Day 5)
Change in Affective Conditioned Hallucinations Task Parameters
Change in individual-level information-processing parameters (Hierarchical Gaussian Filter modeling) derived from an affective variant of the Conditioned Hallucinations task.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Social Appraisal Task Parameters
Change in HGF-derived parameters of social inference and belief updating.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Beads Task Parameters
Change in probabilistic reasoning bias related to delusion-proneness.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Prisoner's Dilemma Task Parameters
Change in HGF-derived parameters of social inference.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Change in clinician-rated depressive symptom severity. Total scores range from 0 to 60, with higher scores indicating greater severity.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Quick Inventory of Depressive Symptomatology (QIDS) Score
Change in self-reported depressive symptom severity on the Quick Inventory of Depressive Symptomatology, 16-item Self-Report (QIDS-SR16). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Time frame: Baseline, Daily from Day 1 to Day 5, and at 1 week, 1 month, and 3 months post-treatment
Change in Heart Rate During Task Performance
Heart rate recorded via BIOPAC physiological monitoring during the computational task battery, measured in beats per minute (bpm).
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Galvanic Skin Response During Task Performance
Galvanic skin response (electrodermal activity) recorded via BIOPAC physiological monitoring during the computational task battery, measured in microsiemens (µS).
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Sleep Consolidation
Sleep consolidation (e.g., sleep efficiency, wake after sleep onset) recorded via Fitbit wearable device.
Time frame: Continuous, from 2-week baseline lead-in through 3-month follow-up
Change in Daytime Activity Level
Daytime activity level (e.g., step count) recorded via Fitbit wearable device.
Time frame: Continuous, from 2-week baseline lead-in through 3-month follow-up
Change in Geolocation-Based Mobility
Geolocation-based mobility patterns (e.g., time spent away from home, location variability) recorded via mindLAMP passive sensing.
Time frame: Continuous, from 2-week baseline lead-in through 3-month follow-up
Change in Phone Usage Patterns
Smartphone usage patterns (e.g., screen time, app engagement) recorded via mindLAMP passive sensing.
Time frame: Continuous, from 2-week baseline lead-in through 3-month follow-up
Change in Facial Expressivity
Facial expressivity recorded via the EMOCARE application using automated facial action unit analysis.
Time frame: Continuous, from 2-week baseline lead-in through 3-month follow-up
Change in Vocal Prosody
Vocal prosody (e.g., pitch variability, speech rate) recorded via the EMOCARE application.
Time frame: Continuous, from 2-week baseline lead-in through 3-month follow-up
Change in Speech Coherence
Linguistic coherence features (e.g., semantic coherence) extracted from structured speech samples (Quebec Speech Bank), associated with thought disorder.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Speech Prosody
Prosodic features (e.g., pitch, pause duration) extracted from structured speech samples (Quebec Speech Bank), associated with negative symptoms.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Structured Interview for Psychosis-Risk Syndromes (SIPS) Positive Symptom Score
Sum of the 5 SIPS positive symptom severity items (P1-P5), each rated 0-6. Total scores range from 0 to 30, with higher scores indicating greater positive symptom severity.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Scale for the Assessment of Negative Symptoms (SANS) Total Score
Sum of the 4 global rating items across the Affective Flattening or Blunting, Alogia, Avolition-Apathy, and Anhedonia-Asociality subscales, each rated 0-5. Total scores range from 0 to 20, with higher scores indicating greater negative symptom severity.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Scale for the Assessment of Positive Symptoms (SAPS) Score
Sum of the 4 global rating items across the Hallucinations, Delusions, Bizarre Behavior, and Positive Formal Thought Disorder subscales, each rated 0-5. Total scores range from 0 to 20, with higher scores indicating greater positive symptom severity.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Total scores range from 30 to 210, with higher scores indicating greater overall symptom severity.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in Social and Occupational Functioning Assessment Scale (SOFAS) Score
Scores range from 0 to 100, with higher scores indicating better functioning.
Time frame: Baseline to 1 week, 1 month, and 3 months post-treatment
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Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 24 months is below that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
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Douglas Mental Health University Institute