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The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia

NCT00523445 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-08-06

No results posted yet for this 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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Inje University

    lead OTHER

Principal Investigators

  • Joo-Cheol Shim, MD.PhD · Inje University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00523445 on ClinicalTrials.gov