Manhattan Psychiatric Center
New York, 10035, United States
NCT Number: NCT00548470
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
New York, 10035, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Varenicline 1-2 mg/day
Other names: Chantix
Time frame: Baseline and during 2 months of treatment
Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.
Time frame: baseline and during 2 months of treatment
Carbon Monoxide in breath ,parts per million
Time frame: baseline 1 month and 2 months
cotinine level in plasma ng/ml.
Time frame: baseline and month 2 of treatment
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.
Time frame: Baseline and 2 months later
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.
Nathan Kline Institute for Psychiatric Research
Other
Evaluation of Varenicline's Clinical Efficacy for Continued Smoking Abstinence When Used in the Clinical Treatment of Schizophrenic Patients Hospitalized in an Institution With a Ban on Cigarette Smoking
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