Using accelerated magnetic stimulation to improve cognition in schizophrenia patients on clozapine

Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment

This study is testing if a new brain stimulation technique can help improve thinking skills in people with schizophrenia who are taking clozapine.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06003036 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of accelerated intermittent theta burst stimulation (iTBS) on neurocognition in individuals diagnosed with schizophrenia or schizoaffective disorder who are being treated with clozapine. Participants will undergo both iTBS and sham stimulation sessions, with the order of these sessions randomized and blinded to ensure unbiased results. The study aims to determine if iTBS can enhance cognitive function compared to sham treatment, following baseline evaluations and MRI scans.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-50 with a diagnosis of schizophrenia or schizoaffective disorder who have been on clozapine for at least four months.

Not a fit: Patients with serious neurological conditions, significant risk of self-harm, or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve cognitive functioning in patients with schizophrenia who are currently receiving clozapine treatment.

How similar studies have performed: While the specific approach of accelerated iTBS is novel, similar studies using transcranial magnetic stimulation have shown promise in enhancing cognitive functions in various psychiatric conditions.

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.

Where this trial is running

Pittsburgh, Pennsylvania

• UPMC Western Psychiatric Hospital/University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Deepak K Sarpal, M.D. — University of Pittsburgh
• Study coordinator: Tori Blazinski

Conditions: Schizophrenia, Schizoaffective Disorder