- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223418
Study Comparing Patients Taking Olanzapine and Patients Taking Aripiprazole on Learning of Vocational Skills
April 5, 2013 updated by: Dawn Velligan, The University of Texas Health Science Center at San Antonio
Do Patients Taking Aripiprazole Learn More in Vocational Skills Training Than Patients Taking Olanzapine?
STUDY PURPOSE: To study whether patients who have schizophrenia or schizoaffective disorder and are randomly assigned to switch to aripiprazole prior to participation in a brief vocational skills training (VST) will have improved cognitive functioning and learn more in VST than those randomly assigned to stay on olanzapine.
There is evidence that VST is important in improving role functioning for schizophrenia patients, however, cognitive impairments limit the ability of some patients to benefit from skills training approaches.
Patients switched from olanzapine to aripiprazole improve in terms of verbal learning and verbal learning has been shown to be a strong predictor of community outcome.
It is unclear whether the cognitive benefits of switching to aripiprazole extend to improve learning of vocational skills.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Many schizophrenia outpatients have cognitive deficits and poor vocational functioning.
There is evidence from randomized controlled trials that vocational skills training is important in improving vocational role functioning for schizophrenia patients.
However, it has become clear that cognitive impairments limit the ability of patients to benefit from skills training approaches.
Recent research demonstrates that patients switched from olanzapine to aripiprazole improve in terms of verbal learning.
Verbal learning has been found to be a strong predictor of multiple domains of community outcome.
It is unclear whether the cognitive benefits of switching to aripiprazole extend to improve learning of vocational skills.
This study examines whether aripiprazole can improve the ability to benefit from expensive rehabilitation programs focused on skill-building.
Specifically, the study examines whether patients who switch from olanzapine to aripiprazole learn more and benefit more from a brief vocational skills program than patients who remain on olanzapine.
Specific aims are as follows: (1) we hypothesize that patients on aripiprazole will demonstrate better scores on tests of cognitive functioning following twelve weeks of medication treatment than patients on olanzapine and (2) we hypothesize that patients on aripiprazole will have significantly higher scores on vocational performance following a brief (2-day) vocational training and assessment session than those on olanzapine.
Furthermore, we hypothesize that these gains will be maintained following one week of non-exposure to the trained vocational tasks.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- The University of Texas Health Science Center at San Antonio
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 52 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- Between ages of 18 and 52
- On olanzapine for a minimum of 3 months prior to participation
- Outpatient status for at least 3 months
- Vision and hearing intact or corrected to extent that will allow participation in vocational training and cognitive testing
- Score in impaired range on at least one test from a cognitive battery designed to be sensitive to impairments in schizophrenia
- Ability to participate in the informed consent process, as evidenced by an assessment of the capacity to give consent for research developed by the Maryland Psychiatric Research Center (DeRenzo et al., 1998).
Exclusion Criteria:
- History of head injury, mental retardation or neurological disorder
- Below a 4th grade reading level (32) according to the WRAT-3
- Taking multiple atypical antipsychotics
- Taking any decanoate antipsychotic
- Hospitalization in last 3 months
- Employment
- Alcohol or drug abuse that interferes with functioning or medication compliance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Toilet Tank Assembly Task at 13 and 14 weeks
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Card Sorting Task at baseline, 13 and 14 weeks
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Secondary Outcome Measures
Outcome Measure |
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Brief Psychiatric Rating Scale at baseline and 13 week
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Negative Symptom Assessment at baseline and 13 week
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Global Assessment of Functioning Scale at baseline and 13 week
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Social and Occupational Functioning Scale at baseline and 13 week
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Work portion of Test of Adaptive Behaviors in Schizophrenia at baseline and 13 week
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STAN neurocognitive tests at baseline and 13 week
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Trails A at baseline and 13 week
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Trails Aa at baseline and 13 week
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Trails B at baseline and 13 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dawn I Velligan, Ph.D., University of Texas Health Science Center in San Antonio
- Study Director: Mary D. Woolsey, M.S., The University of Texas Health Science Center at San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
April 8, 2013
Last Update Submitted That Met QC Criteria
April 5, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Disease
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 023-0013-300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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