Accelerated brain stimulation to reduce negative symptoms of schizophrenia
Official title: Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
Run by Douglas Mental Health University Institute · NCT07428460 · Data updated 2026-11-12
This will test whether a fast course of noninvasive brain stimulation given over five days can help people with schizophrenia who have marked negative symptoms like low motivation and reduced emotional expression.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Douglas Mental Health University Institute Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | December 2027 |
| Study ends | May 2028 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07428460 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed schizophrenia-spectrum diagnosis, clinically significant and stable negative symptoms, at least six months of illness duration, stable medications for four weeks, capacity to consent, and eligibility for MRI and TMS are ideal candidates.
✕Probably not a fit
People with contraindications to TMS or MRI, a recent history of ECT or prior rTMS, active uncontrolled substance use (other than cannabis), pregnancy, or predominant positive symptoms are less likely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, sham-controlled pilot uses an accelerated intermittent theta-burst stimulation (iTBS) protocol delivered over five consecutive days to target negative symptoms in people with schizophrenia spectrum disorders. Participants are randomized to active or sham stimulation and to one of two targeting methods for placing the stimulation, with treatment guided by neuronavigation or a scalp-based approach. All participants complete baseline clinical interviews, questionnaires, and a brain scan, then receive the condensed treatment course and return for post-treatment outcome assessments. Primary outcomes focus on changes in negative symptom severity, while secondary outcomes include depressive symptoms, functional measures, and safety/tolerability.
Why it matters
Potential benefit: If successful, the approach could reduce negative symptoms such as low motivation and social withdrawal and improve day-to-day functioning with a short, more accessible treatment schedule.
How similar studies have gone: Prior rTMS studies targeting the left dorsolateral prefrontal cortex have shown some benefit for negative symptoms, but accelerated multi-session-per-day iTBS protocols are newer and less extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder * Duration of illness ≥ 6 months * Clinically significant negative symptoms * Must have been on a stable pharmacological treatment for at least 4 weeks before entering the study * Clinicians will confirm that patients' negative and positive symptoms have been stable per their clinical opinion for at least 3 months. * Participants must be able to provide informed consent * Ability to undergo MRI scanning Exclusion Criteria: * Pregnancy, lactation, or an intrauterine device * History of electroconvulsive therapy (ECT) in the past 6 months * Use of licit or illicit substances (excluding cannabis) during the week of treatment and in the 24 hours prior to fMRI scans * Contraindications for TMS * Previous treatment with rTMS * Documented history of significant intellectual disability * Primary diagnosis of psychotic disorder secondary to a medical condition or substance-induced psychosis.
Where it's running
-
McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC
Verdun, Quebec, Canada Recruiting -
Institut Universitaire en Santé Mentale de Montréal
Montreal, Quebec, Canada Not yet recruiting -
Institut universitaire de santé mentale de Québec - Centre de recherche CERVO
Québec, Quebec, Canada Not yet recruiting
Study contacts
- Principal investigator: David Benrimoh, MD.CM., MSc., MSc., FRCPC — McGill University, Department of Psychiatry
- Study coordinator: Ashley S. Choucroun
- Email: ashley.choucroun.comtl@ssss.gouv.qc.ca
- Phone: 5146593488
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.