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This study aims to determine how clozapine treatment improves neuronal measures of sensory gating in subjects with schizophrenia.
This study will use functional magnetic resonance imaging (fMRI) to study patients treated with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those treated with clozapine to determine which brain areas are involved in clozapine's normalization of sensory gating in schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| risperidone | |||
| clozapine | Patients with schizophrenia treated with clozapine |
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| Measure | Description | Time Frame |
|---|---|---|
| Neuronal Response During Sensory Gating | Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli. | Immediate |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with schizophrenia
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| Name | Affiliation | Role |
|---|---|---|
| Jason R. Tregellas, PhD | VA Eastern Colorado Health Care System, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Eastern Colorado Health Care System, Denver | Denver | Colorado | 80220 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Risperidone | Patients with schizophrenia treated with risperidone |
| FG001 | Clozapine | Patients with schizophrenia treated with clozapine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Individuals with schizophrenia.
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| ID | Title | Description |
|---|---|---|
| BG000 | Risperidone | Patients with schizophrenia treated with risperidone |
| BG001 | Clozapine | Patients with schizophrenia treated with clozapine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neuronal Response During Sensory Gating | Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli. | Posted | Mean | Standard Deviation | % BOLD signal | Immediate |
|
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Serious/non-serious adverse events related to group membership were not assessed for this observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risperidone | Patients with schizophrenia treated with risperidone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Biologist | Denver VA Medical Center | 303-724-6232 | jason.tregellas@va.gov |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Clozapine | Patients with schizophrenia treated with clozapine | 0 | 0 | 0 | 0 |
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