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

This study is currently recruiting participants.

Verified April 2010 by Nathan Kline Institute for Psychiatric Research

First Received on December 4, 2008. Last Updated on July 22, 2011 History of Changes

Sponsor:	Nathan Kline Institute for Psychiatric Research
Information provided by:	Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:	NCT00802919

Purpose

This is a 12-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. 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 hsitory of regular smokers.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Schizophrenia Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:

Cotinine Level [ Time Frame: monthly ] [ Designated as safety issue: No ]
Scores on MATRICS Neuropsychological Battery [ Time Frame: baseline and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PANSS Total Score [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
Hamilton Depression Scale Score [ Time Frame: baseline and end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Primary Completion Date:	December 2012 (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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802919

Locations

United States, New York
Manhattan Psychatirc Center	Recruiting
New York City, New York, United States, 10035
Contact: Hannah Baldwin, MA 646-672-6964 Marchdb@omh.state.ny.us
Principal Investigator: Robert C Smith, MDm PhD
Nathan Kline Insitute for Psychiatric Research	Not yet recruiting
Orangeburg,, New York, United States, 10962
Contact: Lawrence Maayan, MD 845-398-6637 lmaayan@nki.rfmh.org
Principal Investigator: Lawrence Maayan, MD
Israel
The Division of Psychiatry, Chaim Sheba Medical Center	Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: Revital Amiaz, MD +972-3-530-3774 revital.amiaz@sheba.health.gov.il
Principal Investigator: Revital Amiaz, MD

Sponsors and Collaborators

Nathan Kline Institute for Psychiatric Research

Investigators

Principal Investigator:

Robert C. Smith, MD, PhD

Manhattan Psychiatric Center

More Information

No publications provided

Responsible Party:	Robert C. Smith MD PhD, NYU School of Medicine & Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:	NCT00802919 History of Changes
Other Study ID Numbers:	081/C02, FDA IND 102,411
Study First Received:	December 4, 2008
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nathan Kline Institute for Psychiatric Research:

schizophrenia
smoking
nicotine
cognitive deficits

DNMT1 mRNA
nicotinic receptors
Cognitive Deficits in Schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Smoking
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Habits
Varenicline
Nicotinic Agonists

Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012