Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Completed · Phase 4 · Has a placebo group
Conditions studied: Schizophrenia, Cigarette Smoking
In brief
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.
Key facts
- Study ID
- NCT00802919
- Run by
- Nathan Kline Institute for Psychiatric Research
- People needed
- 93
- Starts
- 2008-09-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2017-12-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication
You may not qualify if…
- 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
Where it is running
- Manhattan Psychatirc Center — New York, New York, United States
- Nathan Kline Insitute for Psychiatric Research — Orangeburg, New York, United States
- Peking University Institute of Mental Health — Beijing, China
- The Division of Psychiatry, Chaim Sheba Medical Center — Tel Litwinsky, Israel
Full record on ClinicalTrials.gov
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