The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

August 3, 2009 updated by: Inje University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • BUsan, Korea, Republic of, 616-824
        • Ahab Hospital
      • Busan, Korea, Republic of, 614-735
        • Busan Paik Hospital
      • Busan, Korea, Republic of, 609-370
        • Dongrae Hospital
      • Busan, Korea, Republic of, 612-827
        • Jamyeong
      • Masan, Korea, Republic of, 630-856
        • Dongseo hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically stable patients with schizophrenia

Exclusion Criteria:

  • Refractory schizophrenia
  • Mental Retardation
  • Serious Medical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicline
The effect of varenicline on cognitive function of Varenicline(Chantix) is being compared to that of placebo
Drug: Varenicline(Chantix)
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
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effect of this combination therapy on smoking in people with schizophrenia.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: Joo-Cheol Shim, MD.PhD, Inje University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Varenicline07
  • 07TAS-1051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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