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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH062134 | U.S. NIH Grant/Contract | View source | |
| R01MH080066 | U.S. NIH Grant/Contract | View source |
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Study was terminated due to low accrual.
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. This application proposes a series of integrated behavioral studies designed to identify causes of deficits in schizophrenia.
We will be assessing clinical symptoms and cognition before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antipsychotic | Experimental | Antipsychotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antipsychotic | Drug | Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline. | Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John A Sweeney, PhD | UIC/UTSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UIC Center for Cognitive Medicine | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antipsychotic | Antipsychotic treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antipsychotic | Antipsychotic treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline. | Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms. | Completers | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 weeks |
|
|
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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 | Antipsychotic | Antipsychotic treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EPS | Nervous system disorders | Systematic Assessment | Extrapyramidal side effects assessed with Simpson Angus Rating Scale |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Bishop | Ullinois | 312-413-3495 | jbishop@uic.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014150 | Antipsychotic Agents |
| ID | Term |
|---|---|
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 0 |
| 12 |
| 2 |
| 12 |
|
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| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |