Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine (NCT06003036) | Clinical Trial Compass
RecruitingNot Applicable
Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
United States30 participantsStarted 2023-12-01
Plain-language summary
In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
✓. age 18-50 years
✓. at least 4 months of clozapine treatment
✓. history of at least 2 failed antipsychotic trials
✓. competency and willingness to sign informed consent
✓. A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg/day
Exclusion criteria
✕. Serious neurologic or medical condition/treatment that impacts the brain
✕. a significant risk of suicidal or homicidal behavior
✕. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
✕. pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
What they're measuring
1
change in brain functional connectivity within the prefrontal cortex
Timeframe: 1 hour
2
change in activation of the working memory network
✕. history of treatment with electroconvulsive therapy
✕. contraindications for magnetic resonance imaging (e.g., a pacemaker)
✕. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-verified moderate or severe substance use disorder, including alcohol use disorder
✕. seizure disorder or prior history of seizures on clozapine