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Zyprexa and Task Engagement in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440843
Recruitment Status : Withdrawn
First Posted : February 27, 2007
Last Update Posted : December 23, 2013
Clinical Trials Network of Columbia U, Cornell U, and NY Presbyterian Hospital
Eli Lilly and Company
Information provided by (Responsible Party):
Jimmy Choi, VA Connecticut Healthcare System

Brief Summary:
Individuals with schizophrenia frequently have impairments in attention. These impairments have been shown to be related to overall functioning. Some research suggests that Olanzapine may be associated with improvement in various aspects of attention. The primary purpose of this study is to determine whether switching from a typical antipsychotic to Olanzapine improves task engagement. Individuals who taking typical antipsychotics will be randomly assigned to either 1) remain on their typical antipsychotic medications, or 2) be switched from their typical antipsychotic medications to Olanzapine. All participants will be enrolled in a twice-weekly 20 session cognitive training program that is specifically designed to target attention deficits and promote active engagement. Improvements in attention will be compared between individuals who remained on their typical antipsychotic medications and those that were switched to Olanzapine.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Olanzapine (Zyprexa) Drug: Typicals Phase 3

Detailed Description:

Objectives: Olanzapine (OLZ) has emerged as one of the promising pharmacologic interventions that not only improves psychotic symptoms but may also target ability to sustain attention on cognitive tests. Pupillary response, as measured by degree of pupil constriction, and visual scanning patterns are unique methods of quantifying attention by gauging the level of psychophysiologic engagement on a visual task. It is reasonable to expect that if a treatment for attention problems is effective, then this will be reflected in more efficient allocation of psychophysiologic attentional resources as measured by pupillometry. Primary purpose of this pilot study is to demonstrate efficacy of switching to OLZ for improving task engagement in schizophrenia. Secondary objectives are to demonstrate improved attention in response to OLZ translates to improved attentional allocation strategies and vocational readiness, and demonstrate efficacy of OLZ as agent that enhances ability to benefit from cognitive training. The proposed study will examine functional implications of improved attention in patients taking OLZ, and it will test the hypothesis that mechanism of this functional improvement is through process of engagement as measured by pupillometry and functional behavioral measures.

Research Design and Methodology: This is an industry-sponsored, investigator initiated trial with 18 patients in an open-label design over 24-month period. Participants will be adult outpatients (ages 18 to 55) with a diagnosis of schizophrenia or schizoaffective disorder who are on any regimen of "typical" antipsychotics. They will be randomly assigned to one of two conditions: 1) Olanzapine Group (OLZ-G). Subjects assigned to the OLZ condition will be switched to OLZ from their previous medication so OLZ is the only antipsychotic medication part of their regimen. Following switch to OLZ, subjects will be enrolled in a twice weekly, 20-session cognitive training program that is specifically designed to target attention deficits and promote active engagement. 2) "Typicals" Group (TYP-G). Subjects assigned to the "typicals" condition will continue with their medication regimen throughout the course of the study as they are enrolled in the same cognitive training program. Research questions are: Compared to participants on any combination of "typical" medications, we hypothesize that persons with schizophrenia on OLZ will (a) show significantly improved performance on psychophysiologic measure of task engagement, (b) show greater engagement in cognitive training, and (c) show greater improvement in attention on vocational task. Primary efficacy measure will be an ASL H6 Series head-mounted optics pupillometer to measure task engagement as function of pupil dilation and visual scanning patterns. Secondary efficacy measures will include computer software specifically developed to assess on-task behavior on computer exercises, brief neuropsychological test battery, global behavior and symptom inventories, and functional assessment of treatment motivation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Olanzapine in Improving Task Engagement in Schizophrenia
Study Start Date : February 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: OLZ Drug: Olanzapine (Zyprexa)

Active Comparator: Typicals Drug: Typicals
Stay on typicals regimen

Primary Outcome Measures :
  1. Pupillometry [ Time Frame: Baseline, post ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Current medication regimen that includes any combination of first generation neuroleptics, for at least 30 days
  • Referring psychiatrist agrees to transfer primary psychiatric care and medication prescription to the study doctor, for the duration of patient's participation in the study

Exclusion Criteria:

  • Significant auditory/visual impairment that would interfere with study procedures
  • Lack of aptitude in English that may interfere with the administration of the tests
  • Current use of psychoactive substances that may affect attention (e.g. Amoxetine, Methylphenidate)
  • Deviations from the prescription regimen not approved by study doctor
  • Changes in the regimen of antipsychotics not included in the study's protocol
  • Chart diagnosis of any other medical or neuropsychiatric illnesses known to impair brain function (e.g. mental retardation, traumatic brain injury, seizure disorder).
  • Pregnant or breast-feeding females.
  • Use of alcohol or drugs 4 weeks prior to beginning of study.
  • For participants with history of substance dependence (excluding nicotine and caffeine) use of illicit substances (e.g. marijuana or crack) during study participation.
  • Use of a depot antipsychotic within 4 weeks prior to baseline
  • History or evidence of a medical or neurological condition that would expose the subject to an undue risk of a significant adverse event or interfere with study assessments
  • Clinically significant abnormal laboratory test results at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00440843

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
VA Connecticut Healthcare System
Clinical Trials Network of Columbia U, Cornell U, and NY Presbyterian Hospital
Eli Lilly and Company
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Principal Investigator: Jimmy Choi, Psy.D. Columbia University
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Responsible Party: Jimmy Choi, Assistant Professor, VA Connecticut Healthcare System Identifier: NCT00440843    
Other Study ID Numbers: JC0002
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013
Keywords provided by Jimmy Choi, VA Connecticut Healthcare System:
task engagement
cognitive rehabilitation
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents