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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Experimental | open label varenicline 2mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Varenicline 1-2 mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Self Report of Smoking | Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week. | Baseline and during 2 months of treatment |
| CO (Carbon Monoxide) Breathalyzer Level | Carbon Monoxide in breath ,parts per million | baseline and during 2 months of treatment |
| Plasma Cotinine | cotinine level in plasma ng/ml. | baseline 1 month and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| RBANS Neuropsychological Battery | The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Smith, MD, PhD | Nathan Kline Institute of Psychiatric Research; NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Psychiatric Center | New York | New York | 10035 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19251401 | Result | Smith RC, Lindenmayer JP, Davis JM, Cornwell J, Noth K, Gupta S, Sershen H, Lajtha A. Cognitive and antismoking effects of varenicline in patients with schizophrenia or schizoaffective disorder. Schizophr Res. 2009 May;110(1-3):149-55. doi: 10.1016/j.schres.2009.02.001. Epub 2009 Feb 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenciline | open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenciline | open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day |
| 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 | Self Report of Smoking | Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week. | Posted | Mean | Standard Deviation | Cigarettes | Baseline and during 2 months of treatment |
|
|
12 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 | Varenicline | open label varenicline 2mg/day Varenicline: Varenicline 1-2 mg/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment | nausea reported on varenicline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert C Smith MD | Nathan Kline Institute for psychaitric Research | 845-398-6531 | rsmith@nki.rfmh.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D014029 | Tobacco Use Disorder |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| baseline and month 2 of treatment |
| Change From Baseline in Psychiatric Symptoms | The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology. | Baseline and 2 months later |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | CO (Carbon Monoxide) Breathalyzer Level | Carbon Monoxide in breath ,parts per million | Posted | Mean | Standard Deviation | ppm (carbon monoxide parts per million) | baseline and during 2 months of treatment |
|
|
|
| Primary | Plasma Cotinine | cotinine level in plasma ng/ml. | Posted | Mean | Standard Deviation | ng/ml | baseline 1 month and 2 months |
|
|
|
| Secondary | RBANS Neuropsychological Battery | The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability. | Posted | Mean | Standard Deviation | RBANS scores | baseline and month 2 of treatment |
|
|
|
| Secondary | Change From Baseline in Psychiatric Symptoms | The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology. | Posted | Mean | Standard Deviation | Units on the PANSS scale | Baseline and 2 months later |
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
|
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| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D011810 | Quinoxalines |
|
| Title | Measurements |
|---|---|
|
| RBANS list learning 2 months |
|
| RBANS visuospatal index baseline |
|
| RBANS visuospatial index 2 months |
|
| RBANS language index baseline |
|
| RBANS language index 2 months |
|
| Title | Measurements |
|---|---|
|
| PANSS Positive 2 months |
|