Schizophrenia Clinical Trials

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Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. We 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 questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment This study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Institut Universitaire en Santé Mentale de Montréal
NOT_YET_RECRUITING
Montreal
Institut universitaire de santé mentale de Québec - Centre de recherche CERVO
NOT_YET_RECRUITING
Québec
McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QC
RECRUITING
Verdun
Contact Information
Primary
Ashley S. Choucroun
ashley.choucroun.comtl@ssss.gouv.qc.ca
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2028-05
Participants
Target number of participants: 75
Treatments
Experimental: Active iTBS (Neuronavigated Targeting)
Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using neuronavigation-guided targeting.
Experimental: Active iTBS (BEAM-F3 Targeting)
Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using BEAM-F3 targeting.
Sham_comparator: Sham iTBS
Participants receive sham iTBS over five consecutive days (ten sessions/day) using the same session structure and procedures as active treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal, Magnus Medical, Centre de recherche CERVO
Leads: Douglas Mental Health University Institute

This content was sourced from clinicaltrials.gov