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The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

Information source: Inje University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Varenicline(Chantix) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Inje University

Official(s) and/or principal investigator(s):
Joo-Cheol Shim, MD.PhD, Principal Investigator, Affiliation: Inje University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia.

Secondary outcome: To evaluate the effect of this combination therapy on smoking in people with schizophrenia.

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinically stable patients with schizophrenia

Exclusion Criteria:

- Refractory schizophrenia

- Mental Retardation

- Serious Medical illness

Locations and Contacts

Ahab Hospital, BUsan 616-824, Korea, Republic of

Busan Paik Hospital, Busan 614-735, Korea, Republic of

Dongrae Hospital, Busan 609-370, Korea, Republic of

Jamyeong, Busan 612-827, Korea, Republic of

Dongseo hospital, Masan 630-856, Korea, Republic of

Additional Information

Starting date: September 2007
Last updated: August 3, 2009

Page last updated: August 23, 2015

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