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Varenicline Adjunctive Treatment in Schizophrenia

NCT00492349 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2022-01-05

Study results available
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Summary

The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder

Interventions

DRUG

Varenicline

Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks

DRUG

Placebo

Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • L. Elliot Hong, M.D. · Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-05-31
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00492349 on ClinicalTrials.gov