Zyprexa and Task Engagement in Schizophrenia

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00440843
First received: February 25, 2007
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Olanzapine (Zyprexa)
Drug: Typicals
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Olanzapine in Improving Task Engagement in Schizophrenia

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Pupillometry [ Time Frame: Baseline, post ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OLZ Drug: Olanzapine (Zyprexa)
OLZ
Active Comparator: Typicals Drug: Typicals
Stay on typicals regimen

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440843

Locations
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
Investigators
Principal Investigator: Jimmy Choi, Psy.D. Columbia University
  More Information

No publications provided

Responsible Party: Jimmy Choi, Assistant Professor, VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT00440843     History of Changes
Other Study ID Numbers: JC0002, F1D-US-X282
Study First Received: February 25, 2007
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
schizophrenia
attention
task engagement
antipsychotics
cognition
cognitive rehabilitation

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 18, 2014