NCT06003036 · Deepak K. Sarpal, M.D.
Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
- patients taking both bupropion and clozapine
- 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.
Where
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations