Accelerated Transcranial Magnetic Stimulation for People with Schizophrenia Treated with Clozapine

Launched by DEEPAK K. SARPAL, M.D. · Aug 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called accelerated intermittent theta burst stimulation (iTBS) to see if it can help improve thinking and brain function in people with schizophrenia or schizoaffective disorder who are already taking a medication called clozapine. The researchers want to find out if this new approach can enhance the benefits of clozapine. Participants in the study will go through some evaluations, including an MRI scan, and will have two different sessions: one with the active treatment and another with a placebo (a treatment that doesn’t have any active effect). The order of these sessions will be random, meaning it’s like a flip of a coin to decide which treatment they receive first.

To be eligible for this trial, participants need to be between 18 and 50 years old, currently diagnosed with schizophrenia or schizoaffective disorder, and have been treated with clozapine for at least 4 months. They should also have tried other antipsychotic medications that didn’t work before. Participants can expect to undergo assessments and treatment sessions that involve advanced brain imaging. It's important to know that some people may not qualify due to certain health conditions or medications, so those interested should discuss their specific situation with a healthcare professional.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
• • 2. age 18-50 years
• • 3. at least 4 months of clozapine treatment
• • 4. history of at least 2 failed antipsychotic trials
• • 5. competency and willingness to sign informed consent
• • 6. A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg/day
• Exclusion Criteria:
• • 1. Serious neurologic or medical condition/treatment that impacts the brain
• • 2. a significant risk of suicidal or homicidal behavior
• • 3. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
• • 4. pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
• • 5. history of treatment with electroconvulsive therapy
• • 6. contraindications for magnetic resonance imaging (e.g., a pacemaker)
• • 7. 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
• • 8. seizure disorder or prior history of seizures on clozapine
• • 9. patients taking both bupropion and clozapine
• • 10. prior issues with intermittent theta burst stimulation/transcranial magnetic stimulation administration
• • Concomitant treatment with serotonin and norepinephrine reuptake inhibitors will be examined on a case-by-case basis.