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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00802919
First Posted: December 5, 2008
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
  Purpose
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.

Condition Intervention Phase
Schizophrenia Cigarette Smoking Drug: Varenicline Drug: Placebo for varenicline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study

Resource links provided by NLM:


Further study details as provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Cotinine Level [ Time Frame: Baseline, 4 weeks, 8 weeks ]
    plasma cotinine

  • 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.


Secondary Outcome Measures:
  • Change From Baseline in Psychiatric Symptoms [ Time Frame: baseline, 4 weeks, 8 weeks ]
    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.

  • Change From Basellne in Calgary Depression Scale Score [ Time Frame: baseline, 4 weeks, 8 weeks ]
    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.


Enrollment: 93
Study Start Date: September 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline
Varenciline 1-2 mg/day
Drug: Varenicline
Varenicline 1-2 mg/day
Other Name: Chantix
Placebo Comparator: Matched Placebo
placebo for varenicline
Drug: Placebo for varenicline
Placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802919


Locations
United States, New York
Manhattan Psychatirc Center
New York, New York, United States, 10035
Nathan Kline Insitute for Psychiatric Research
Orangeburg, New York, United States, 10962
China
Peking University Institute of Mental Health
Beijing, China, 100191
Israel
The Division of Psychiatry, Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Investigators
Principal Investigator: Robert C. Smith, MD, PhD Nathan Kline Institute for Psychiatric Research
  More Information

Publications:
Responsible Party: Robert C. Smith MD PhD, Research Psychiatrist, Principal Investigagtor, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00802919     History of Changes
Other Study ID Numbers: 081/C02
FDA IND 102,411
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: December 15, 2016
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017
Last Verified: October 2017

Keywords provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:
schizophrenia
smoking
nicotine
cognitive deficits
nicotinic receptors
Cognitive Deficits in Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs