The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia - Full Text View

Purpose

The primary objective of this project is to examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. The secondary objective is to evaluate the effect of this combination therapy on smoking in people with schizophrenia. This study will be a randomized, double blind, parallel group, placebo controlled 8 weeks trial.

Condition	Intervention	Phase
Schizophrenia	Drug: Varenicline(Chantix) Drug: Placebo	Phase 3

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, an Alpha 4 Beta 2 Nicotinic Acetylcholine Receptor Partial Agonist, on Cognitive Dysfunction in 120 Patients With Schizophrenia: a Randomized, Double Blind, 8 Weeks Trial

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 Inje University:

Primary Outcome Measures:

To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effect of this combination therapy on smoking in people with schizophrenia. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	September 2007
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Varenicline The effect of varenicline on cognitive function of Varenicline(Chantix) is being compared to that of placebo	Drug: Varenicline(Chantix) The dose of antipsychotic drug will remain fixed throughout the study and the titration of varenicline will be as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice per day for days 4 to 7, then 1 mg twice per day through week 8.
Placebo Comparator: Placebo The effect of placebo comparator is being compared to that of varenicline	Drug: Placebo The dose of antipsychotic and concomitant medications remained fixed throughout the study and the titration of varenicline was as follows: Placebo will be supplied twice daily through week 8.

Detailed Description:

Cognitive deficits have been considered as a core symptom domain of schizophrenia. Amelioration of or improvement in cognitive impairments is becoming an important focus of clinical treatment development. Varenicline is a potent and selective alpha 4 beta 2 nicotinic acetylcholine receptor partial agonist that has been developed for smoking cessation. In animal studies, alpha 4 beta 2 receptor agonists significantly improve working memory and attention function. Subjects will be assigned in 1:1 ratio to receive varenicline or placebo respectively. Assessments will be done using several neuropsychologic tests, clinical rating scale including assessment of nicotine withdrawal scales.Varenicline has been found to be efficacious for smoking cessation in the general population and animal studies have demonstrated the cognitive benefits of this agent. However, no published work is available evaluating the cognitive effects in humans. Thus, patients may experience improvements in cognitive function and in people who are smokers, these people may be able to achieve abstinence in smoking. This will in turn improve long-term functional outcomes and health outcomes in people with schizophrenia. This is an exciting opportunity for discovery if indeed cognitive abilities could be improved with this adjunctive treatment.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinically stable patients with schizophrenia

Exclusion Criteria:

Refractory schizophrenia
Mental Retardation
Serious Medical illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523445

Locations

Korea, Republic of
Busan Paik Hospital
Busan, Korea, Republic of, 614-735
Dongrae Hospital
Busan, Korea, Republic of, 609-370
Ahab Hospital
BUsan, Korea, Republic of, 616-824
Jamyeong
Busan, Korea, Republic of, 612-827
Dongseo hospital
Masan, Korea, Republic of, 630-856

Sponsors and Collaborators

Inje University

Stanley Medical Research Institute

Investigators

Principal Investigator:

Joo-Cheol Shim, MD.PhD

Inje University

More Information

No publications provided by Inje University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shim JC, Jung DU, Jung SS, Seo YS, Cho DM, Lee JH, Lee SW, Kong BG, Kang JW, Oh MK, Kim SD, McMahon RP, Kelly DL. Adjunctive varenicline treatment with antipsychotic medications for cognitive impairments in people with schizophrenia: a randomized double-blind placebo-controlled trial. Neuropsychopharmacology. 2012 Feb;37(3):660-8. doi: 10.1038/npp.2011.238. Epub 2011 Nov 2.

Responsible Party:	Joo Shim, Inje University Busan Paik Hospital
ClinicalTrials.gov Identifier:	NCT00523445 History of Changes
Other Study ID Numbers:	Varenicline07, 07TAS-1051
Study First Received:	August 30, 2007
Last Updated:	August 3, 2009
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Inje University:

Schizophrenia
Cognition
Varenicline

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 June 13, 2013