The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

NCT ID: NCT00523445

Last Updated: 2009-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-07-31

Brief Summary

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Varenicline

The effect of varenicline on cognitive function of Varenicline(Chantix) is being compared to that of placebo

Group Type: EXPERIMENTAL

Varenicline(Chantix)

Intervention Type: DRUG

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

The effect of placebo comparator is being compared to that of varenicline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinically stable patients with schizophrenia

Exclusion Criteria

• Refractory schizophrenia
• Mental Retardation
• Serious Medical illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Inje University

OTHER

Sponsor Role: lead

Responsible Party

Inje University Busan Paik Hospital

Principal Investigators

Joo-Cheol Shim, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

Dongrae Hospital

Busan, , South Korea

Jamyeong

Busan, , South Korea

Busan Paik Hospital

Busan, , South Korea

Ahab Hospital

Busan, , South Korea

Dongseo hospital

Masan, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Jeon DW, Shim JC, Kong BG, Moon JJ, Seo YS, Kim SJ, Oh MK, Jung DU. Adjunctive varenicline treatment for smoking reduction in patients with schizophrenia: A randomized double-blind placebo-controlled trial. Schizophr Res. 2016 Oct;176(2-3):206-211. doi: 10.1016/j.schres.2016.08.016. Epub 2016 Aug 16.

Reference Type: DERIVED

PMID: 27543252 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22048460 (View on PubMed)

Other Identifiers

07TAS-1051

Identifier Type: -

Identifier Source: secondary_id

Varenicline07

Identifier Type: -

Identifier Source: org_study_id