Actively Recruiting
Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment
Led by Deepak K. Sarpal, M.D. · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
D
Deepak K. Sarpal, M.D.
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a specific type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can improve brain function in people with schizophrenia or schizoaffective disorder who are being treated with clozapine. This study involves adults aged 18 to 50 years who have been on clozapine for at least four months and have a history of at least two unsuccessful antipsychotic treatments. The goal is to see if iTBS can enhance neurocognition compared to a sham (placebo) treatment. Participants will receive two sessions in a randomized, blinded order: one session of iTBS combined with magnetic resonance imaging (MRI) and one session of sham stimulation combined with MRI. Both interventions involve using a device to deliver the magnetic stimulation. The study measures brain activity and connectivity changes during these sessions to assess the effects of the treatment. During the study, participants will undergo baseline evaluations and MRI scans. Researchers will measure changes in functional brain connectivity within the prefrontal cortex and activation of the working memory network shortly after treatment. Additionally, they will explore changes in brain imaging measures related to clozapine blood levels over one month. Safety, adherence, and cognitive effects will be monitored throughout the study, which is expected to last until July 2026.
CONDITIONS
Brief Title
Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A current diagnosis of schizophrenia or schizoaffective disorder based on DSM 5 criteria
- Age between 18 and 50 years
- At least 4 months of treatment with clozapine
- History of at least 2 failed antipsychotic trials
- Competent and willing to provide informed consent
- Clinically optimized clozapine dosage, unchanged for at least 1 month, with a minimum of 150 mg/day
You will not qualify if you...
- Serious neurological or medical conditions or treatments affecting the brain
- Significant risk of suicidal or homicidal behavior
- Cognitive or language difficulties preventing informed consent
- Pregnancy or postpartum status less than 6 weeks after delivery or miscarriage
- History of electroconvulsive therapy
- Contraindications for MRI, such as having a pacemaker
- Moderate or severe substance use disorder confirmed by DSM 5, including alcohol use disorder
- Seizure disorder or prior seizures while on clozapine
- Current use of both bupropion and clozapine
- Previous problems with intermittent theta burst or transcranial magnetic stimulation treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short periods for each intervention with washout in between
Participants receive accelerated transcranial magnetic stimulation or sham stimulation in a crossover design.
Multiple visits for receiving both active and sham stimulation sessions
Duration - Up to 1 month after interventions
Participants are observed to evaluate changes in brain function and treatment effects after stimulation sessions.
Follow-up visits including functional MRI assessments
Trial Site Locations
Total: 1 location
1
UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
T
Tori Blazinski
D
Deepak Sarpal
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here