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Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

RecruitingNAAges 18 Years - 65 YearsAllDouglas Mental Health University Institute
NCT07428460 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time. Participants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation. The investigators want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes Participants will be asked to complete clinical interviews and quest

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📋 Eligibility rules (as published)
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.
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What it tests

  • Neuronavigated Intermittent Theta Burst Stimulation
  • BEAM-F3 Intermittent theta burst stimulation
  • Sham Intermittent Theta Burst Stimulation
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Where

3 sites
Institut Universitaire en Santé Mentale de Montréal
Montreal, Canada
Institut universitaire de santé mentale de Québec - Centre de recherche CERVO
Québec, Canada
McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC
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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