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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH134128 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTBS, then Sham | Experimental |
| |
| Sham, then iTBS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham stimulation | Device | sham delivery of transcranial magnetic stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour |
| 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 | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant treatment with serotonin and norepinephrine reuptake inhibitors will be examined on a case-by-case basis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tori Blazinski | Contact | 412-246-5618 | blazinskit2@upmc.edu | |
| Deepak Sarpal | Contact | sarpaldk@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deepak K Sarpal, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Western Psychiatric Hospital/University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
de-identified individual participant data to the National Institute of Mental Health (NIMH) data archive
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| transcranial magnetic stimulation | Device | accelerated intermittent theta burst stimulation |
|