NCT06003036 Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
| NCT ID | NCT06003036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Deepak K. Sarpal, M.D. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-12-01 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Deepak K Sarpal, M.D.
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06003036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06003036 currently recruiting?
Yes, NCT06003036 is actively recruiting participants. Contact the research team at blazinskit2@upmc.edu for enrollment information.
Where is the NCT06003036 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06003036 clinical trial?
NCT06003036 is sponsored by Deepak K. Sarpal, M.D.. The principal investigator is Deepak K Sarpal, M.D. at University of Pittsburgh. The trial plans to enroll 30 participants.
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