Schizophrenia Clinical Trial
Official title:
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study
Verified date | October 2017 |
Source | Nathan Kline Institute for Psychiatric Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes. Subjects will be current cigarette smokers or history of regular smokers.
Status | Completed |
Enrollment | 93 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication Exclusion Criteria: prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine = 1.5) baseline Hamilton Depression Scores is >20 |
Country | Name | City | State |
---|---|---|---|
China | Peking University Institute of Mental Health | Beijing | |
Israel | The Division of Psychiatry, Chaim Sheba Medical Center | Tel Hashomer | |
United States | Manhattan Psychatirc Center | New York | New York |
United States | Nathan Kline Insitute for Psychiatric Research | Orangeburg | New York |
Lead Sponsor | Collaborator |
---|---|
Nathan Kline Institute for Psychiatric Research |
United States, China, Israel,
Smith R, Amiaz, R,, Tian-Mei S, Maayan L, Jin H, Boules S, et al. (2013): Varenicline effects on smoking, cognition, and psychiatric symptoms in schizophrenia. Neuropsychopharmacology. 38:s273-s434.
Smith RC, Amiaz R, Si TM, Maayan L, Jin H, Boules S, Sershen H, Li C, Ren J, Liu Y, Youseff M, Lajtha A, Guidotti A, Weiser M, Davis JM. Varenicline Effects on Smoking, Cognition, and Psychiatric Symptoms in Schizophrenia: A Double-Blind Randomized Trial. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cotinine Level | plasma cotinine | Baseline, 4 weeks, 8 weeks | |
Primary | Change From Baseline in Cognitive Performance | The MATRICS Consensus Cognitive Battery (MCCB)(Measurement and Treatment Research to Improve Cognition in Schizophrenia) was used to measure cognitive performance. Six Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program (modified beta version) from raw scores on 10 individually administered subtests. The social cognition test was not assessed in this study. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes. | basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks) | |
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). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes. | baseline, 4 weeks, 8 weeks | |
Secondary | Change From Basellne in Calgary Depression Scale Score | The Calgary Depression Scale for Schizophrenia. The scale has 9 items with ratings of 0 to 3 on each item. Total score can vary from 0 to 27. Higher scores indicate more depression. Negative change scores indicate decreasing depression. | baseline, 4 weeks, 8 weeks |
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