Status:
RECRUITING
Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
Lead Sponsor:
Deepak K. Sarpal, M.D.
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-50 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06003036
Start Date
December 1 2023
End Date
July 1 2026
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213