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

NCT00802919 | Completed Phase 4 Results

• 2 other identifiers: 081/C02FDA IND 102,411
• Study Type: interventional
• Target: 93
• Locations: 3 countries
• Sites: 4

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.

Conditions

Schizophrenia; Cigarette Smoking

Keywords

schizophrenia; smoking; nicotine; cognitive deficits; nicotinic receptors; Cognitive Deficits in Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Cotinine Level

  plasma cotinine

  Baseline, 4 weeks, 8 weeks

• Change From Baseline in Cognitive Performance

  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.

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

Secondary Outcomes (2)

• Change From Baseline in Psychiatric Symptoms

  baseline, 4 weeks, 8 weeks

• Change From Basellne in Calgary Depression Scale Score

  baseline, 4 weeks, 8 weeks

Study Arms (2)

Varenicline

EXPERIMENTAL

Varenciline 1-2 mg/day

Drug: Varenicline

Matched Placebo

PLACEBO COMPARATOR

placebo for varenicline

Drug: Placebo for varenicline

Interventions

Varenicline DRUG

Varenicline 1-2 mg/day

Also known as: Chantix

Varenicline

Placebo for varenicline DRUG

Placebo

Matched Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication

You may not qualify if:

• 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

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead

Study Sites (4)

Manhattan Psychatirc Center

New York, New York, 10035, United States

Location

Nathan Kline Insitute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

Peking University Institute of Mental Health

Beijing, 100191, China

Location

The Division of Psychiatry, Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (2)

• 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.

  PMID: 26730716 BACKGROUND

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Schizophrenia; Cigarette Smoking; Smoking; Cognition Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Tobacco Smoking; Behavior; Tobacco Use; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Robert C. Smith MD
• Organization: Nathan Kline Institute for Psychiatric Research

rsmith@nki.rfmh.org

845-398-6531

Study Officials

• Robert C. Smith, MD, PhD

  Nathan Kline Institute for Psychiatric Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist, Principal Investigagtor

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Locations

US (2); CN (1); IL (1)