Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors

This was a double-blind placebo controlled study of varenicline and matched placebo in
patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with
antipsychotic medication and were cigarette smokers. Three sites (2 U.S., 1 Israel) were
supported by the Stanley grant. A similar independently supported study was conducted in
Beijing, China. We were allowed to access these data and combine them for our analysis of
results. Subjects at each site participated in a protocol which was approved by their
institutional IRB. All subjects signed informed consent.

The study evaluated multiple measures of cigarette smoking, cognitive functions by MATRICS
battery (Measurement and Treatment Research to Improve Cognition in Schizophrenia), and
psychiatric symptoms by PANSS (Positive and Negative Symptom Scale), SANS (Schedule For
Assessment Of Negative Symptoms), and Calgary Depression scales. Lymphocytes were collected
for measurement of epigenetically related mRNA's.

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