Zyprexa and Task Engagement in Schizophrenia

NCT00440843 | Withdrawn Phase 3

• 2 other identifiers: JC0002F1D-US-X282
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; attention; task engagement; antipsychotics; cognition; cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• Pupillometry

  Baseline, post

Study Arms (2)

OLZ

EXPERIMENTAL

Drug: Olanzapine (Zyprexa)

Typicals

ACTIVE COMPARATOR

Drug: Typicals

Interventions

Olanzapine (Zyprexa) DRUG

OLZ

OLZ

Typicals DRUG

Stay on typicals regimen

Typicals

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead
• Clinical Trials Network of Columbia U, Cornell U, and NY Presbyterian Hospital: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jimmy Choi, Psy.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 25, 2007
• First Posted: February 27, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

US (1)