RECRUITING

Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment

Quick Facts

Study Start:2023-12-01
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06003036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
  2. 2. age 18-50 years
  3. 3. at least 4 months of clozapine treatment
  4. 4. history of at least 2 failed antipsychotic trials
  5. 5. competency and willingness to sign informed consent
  6. 6. A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg/day
  1. 1. Serious neurologic or medical condition/treatment that impacts the brain
  2. 2. a significant risk of suicidal or homicidal behavior
  3. 3. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
  4. 4. pregnancy or postpartum (\<6 weeks after delivery or miscarriage)
  5. 5. history of treatment with electroconvulsive therapy
  6. 6. contraindications for magnetic resonance imaging (e.g., a pacemaker)
  7. 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. 8. seizure disorder or prior history of seizures on clozapine
  9. 9. patients taking both bupropion and clozapine
  10. 10. prior issues with intermittent theta burst stimulation/transcranial magnetic stimulation administration

Contacts and Locations

Study Contact

Tori Blazinski
CONTACT
412-246-5618
blazinskit2@upmc.edu
Deepak Sarpal
CONTACT
sarpaldk@upmc.edu

Principal Investigator

Deepak K Sarpal, M.D.
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

UPMC Western Psychiatric Hospital/University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Deepak Sarpal

  • Deepak K Sarpal, M.D., PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective Disorder