The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Varenicline(Chantix); Drug: Placebo

• Registration Number: NCT00523445
• Lead Sponsor: Inje University

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.

Study Timeline

• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Study Start: 2007-09
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinically stable patients with schizophrenia

Exclusion Criteria

• Refractory schizophrenia
• Mental Retardation
• Serious Medical illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline	Varenicline(Chantix)	The effect of varenicline on cognitive function of Varenicline(Chantix) is being compared to that of placebo
Placebo	Placebo	The effect of placebo comparator is being compared to that of varenicline

Primary Outcome Measures

Name	Time	Method
To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia.	8 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of this combination therapy on smoking in people with schizophrenia.	8 weeks

Trial Locations

Locations (5)

Dongseo hospital; 🇰🇷 Masan, Korea, Republic of

Dongrae Hospital; 🇰🇷 Busan, Korea, Republic of

Jamyeong; 🇰🇷 Busan, Korea, Republic of

Ahab Hospital; 🇰🇷 BUsan, Korea, Republic of

Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of