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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Nathan Kline Institute for Psychiatric Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00802919
First received: December 4, 2008
Last updated: May 16, 2012
Last verified: May 2012
  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 4

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:


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 ]
  • Calgary Depression Scale Score [ Time Frame: baseline and monthly ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Manhattan Psychatirc Center Completed
New York City, New York, United States, 10035
Nathan Kline Insitute for Psychiatric Research Recruiting
Orangeburg,, New York, United States, 10962
Contact: Lawrence Maayan, MD    845-398-6637    lmaayan@nki.rfmh.org   
Contact: Robert C smith, MD PhD    845-398-6531    rsmith@nki.rfmh.org   
Principal Investigator: Lawrence Maayan, MD         
Israel
The Division of Psychiatry, Chaim Sheba Medical Center 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, 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
Study First Received: December 4, 2008
Last Updated: May 16, 2012
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
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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 September 18, 2014