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Efficacy and Safety Study of Clozapine Augmented by Atomoxetine Versus Clozapine Augmented by Placebo in Patients With Chronic Resistant Schizophrenia

NCT00216281 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2013-03-26

No results posted yet for this study

Summary

This is a randomized, placebo-controlled study to assess the efficacy and safety of ATX augmentation of CLZ as a treatment for the cognitive symptoms of schizophrenia. A total sample size of 126 subjects diagnosed with schizophrenia and being treated with the antipsychotic clozapine will undergo genotyping. These subjects will have an initial assessment at four weeks and regular follow-up assessments for a total period of 52 weeks. These subjects will be randomized to continued treatment with CLZ and augmentation with ATX or Placebo.

Conditions

Interventions

DRUG

Clozapine augmented with atomoxetine up to 40 mg or placebo

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Shekhar, Anantha M.D., Ph.D.

    collaborator INDIV

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Anantha Shekhar, MD, PhD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-10-31
Completion
2008-09-30

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT00216281 on ClinicalTrials.gov