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Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine

ConditionsSchizophreniaSchizoaffective Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorDeepak K. Sarpal, M.D.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • sham stimulation

    Device

    sham delivery of transcranial magnetic stimulation

  • transcranial magnetic stimulation

    Device

    accelerated intermittent theta burst stimulation

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: iTBS, then ShamExperimental treatment 2 interventions
Group B: Sham, then iTBSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

change in brain functional connectivity within the prefrontal cortex

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

Time frame
1 hour
2

change in activation of the working memory network

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

Time frame
1 hour

Secondary outcomes

1

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

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.

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Deepak K. Sarpal, M.D.

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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