NCT00523445

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

1.8 years

First QC Date

August 30, 2007

Last Update Submit

August 3, 2009

Conditions

Schizophrenia

Keywords

SchizophreniaCognitionVarenicline

Outcome Measures

Primary Outcomes (1)

  • To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia.

    8 weeks

Secondary Outcomes (1)

  • To evaluate the effect of this combination therapy on smoking in people with schizophrenia.

    8 weeks

Study Arms (2)

Varenicline

EXPERIMENTAL

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

Drug: Varenicline(Chantix)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Varenicline(Chantix)DRUG

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.

Varenicline
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically stable patients with schizophrenia

You may not qualify if:

  • Refractory schizophrenia
  • Mental Retardation
  • Serious Medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dongrae Hospital

Busan, 609-370, South Korea

Location

Jamyeong

Busan, 612-827, South Korea

Location

Busan Paik Hospital

Busan, 614-735, South Korea

Location

Ahab Hospital

Busan, 616-824, South Korea

Location

Dongseo hospital

Masan, 630-856, South Korea

Location

Related Publications (3)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

  • Jeon DW, Shim JC, Kong BG, Moon JJ, Seo YS, Kim SJ, Oh MK, Jung DU. Adjunctive varenicline treatment for smoking reduction in patients with schizophrenia: A randomized double-blind placebo-controlled trial. Schizophr Res. 2016 Oct;176(2-3):206-211. doi: 10.1016/j.schres.2016.08.016. Epub 2016 Aug 16.

    PMID: 27543252DERIVED

  • Shim JC, Jung DU, Jung SS, Seo YS, Cho DM, Lee JH, Lee SW, Kong BG, Kang JW, Oh MK, Kim SD, McMahon RP, Kelly DL. Adjunctive varenicline treatment with antipsychotic medications for cognitive impairments in people with schizophrenia: a randomized double-blind placebo-controlled trial. Neuropsychopharmacology. 2012 Feb;37(3):660-8. doi: 10.1038/npp.2011.238. Epub 2011 Nov 2.

    PMID: 22048460DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Joo-Cheol Shim, MD.PhD

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

KR(5)