The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia
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.
|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|
- 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 ]
- To evaluate the effect of this combination therapy on smoking in people with schizophrenia. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
The effect of varenicline on cognitive function of Varenicline(Chantix) is being compared to that of placebo
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523445
|Korea, Republic of|
|BUsan, Korea, Republic of, 616-824|
|Busan Paik Hospital|
|Busan, Korea, Republic of, 614-735|
|Busan, Korea, Republic of, 609-370|
|Busan, Korea, Republic of, 612-827|
|Masan, Korea, Republic of, 630-856|
|Principal Investigator:||Joo-Cheol Shim, MD.PhD||Inje University|