The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

Last updated: August 3, 2009
Sponsor: Inje University
Overall Status: Completed

Phase

3

Condition

Schizotypal Personality Disorder (Spd)

Mood Disorders

Psychosis

Treatment

N/A

Clinical Study ID

NCT00523445
Varenicline07
07TAS-1051
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinically stable patients with schizophrenia

Exclusion

Exclusion Criteria:

  • Refractory schizophrenia

  • Mental Retardation

  • Serious Medical illness

Study Design

Total Participants: 120
Study Start date:
September 01, 2007
Estimated Completion Date:
July 31, 2009

Study 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.

Connect with a study center

  • Ahab Hospital

    BUsan, 616-824
    Korea, Republic of

    Site Not Available

  • Busan Paik Hospital

    Busan, 614-735
    Korea, Republic of

    Site Not Available

  • Dongrae Hospital

    Busan, 609-370
    Korea, Republic of

    Site Not Available

  • Jamyeong

    Busan, 612-827
    Korea, Republic of

    Site Not Available

  • Dongseo hospital

    Masan, 630-856
    Korea, Republic of

    Site Not Available

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