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Completed

NCT Number: NCT06003036

Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Western Psychiatric Hospital/University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
  • age 18-65 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 criteria

  • 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.

Treatment and study plan

Sham stimulation

Device

sham delivery of transcranial magnetic stimulation

Transcranial Magnetic Stimulation

Device

accelerated intermittent theta burst stimulation

Primary outcomes

  1. change in brain functional connectivity within the prefrontal cortex

    Time frame: 1 hour

    Examine changes in left dorsolateral prefrontal cortex-basal forebrain functional connectivity following adjunctive accelerated intermittent theta burst stimulation (iTBS)

  2. change in activation of the working memory network

    Time frame: 1 hour

    Examine whether accelerated intermittent theta burst stimulation (iTBS) is associated with functional magnetic resonance imaging (fMRI)-based changes in activation of the working memory network during AX-continuous performance task engagement

Secondary outcomes

  1. explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios

    Time frame: 1 month

    In exploratory analyses we will compare change in dorsolateral prefrontal cortex-basal forebrain functional connectivity and change in working memory network activation in relation to plasma n-desmethylclozapine/clozapine ratios.

Sponsors and collaborators

Lead sponsor

Deepak K. Sarpal, M.D.

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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