Clinical trial NCT00802919: Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Official title: Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Cigarette Smoking
Keywords: schizophrenia
smoking
nicotine
cognitive deficits
nicotinic receptors
Cognitive Deficits in Schizophrenia
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cotinine Level
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change From Baseline in Cognitive Performance
timeFrame: basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)
Secondary outcomes:
measure: Change From Baseline in Psychiatric Symptoms
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change From Basellne in Calgary Depression Scale Score
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Psychatirc Center
state: New York
city: Orangeburg
country: United States
facility: Nathan Kline Insitute for Psychiatric Research
state: New York
city: Beijing
country: China
facility: Peking University Institute of Mental Health
city: Tel Hashomer
country: Israel
facility: The Division of Psychiatry, Chaim Sheba Medical Center
Study officials:
affiliation: Nathan Kline Institute for Psychiatric Research
name: Robert C. Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. PLoS One. 2016 Jan 5;11(1):e0143490. doi: 10.1371/journal.pone.0143490. eCollection 2016.