The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

Inje University

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00523445

Varenicline07

07TAS-1051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically stable patients with schizophrenia

Exclusion criteria

• Refractory schizophrenia
• Mental Retardation
• Serious Medical illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups, including a placebo group

Varenicline

Experimental group

Description:

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

Treatment:

Drug: Varenicline(Chantix)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo