Skip to main content
Clinical Trials/NCT00802919
NCT00802919CompletedPhase 4

Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study

Nathan Kline Institute for Psychiatric Research4 sites in 3 countries93 target enrollmentStarted: September 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
93
Locations
4
Primary Endpoint
Change From Baseline in Cognitive Performance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Varenicline

Experimental

Varenciline 1-2 mg/day

Intervention: Varenicline (Drug)

Matched Placebo

Placebo Comparator

placebo for varenicline

Intervention: Placebo for varenicline (Drug)

Outcomes

Primary Outcomes

Change From Baseline in Cognitive Performance

Time Frame: basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)

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.

Cotinine Level

Time Frame: Baseline, 4 weeks, 8 weeks

plasma cotinine

Secondary Outcomes

  • Change From Basellne in Calgary Depression Scale Score(baseline, 4 weeks, 8 weeks)
  • Change From Baseline in Psychiatric Symptoms(baseline, 4 weeks, 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert C. Smith MD PhD

Research Psychiatrist, Principal Investigagtor

Nathan Kline Institute for Psychiatric Research

Study Sites (4)

Loading locations...

Similar Trials