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
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