Status:
WITHDRAWN
Zyprexa and Task Engagement in Schizophrenia
Lead Sponsor:
VA Connecticut Healthcare System
Collaborating Sponsors:
Clinical Trials Network of Columbia U, Cornell U, and NY Presbyterian Hospital
Eli Lilly and Company
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 associate...
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 tes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00440843
Start Date
February 1 2007
End Date
June 1 2012
Last Update
December 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center
New York, New York, United States, 10032