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Study Comparing Patients Taking Olanzapine and Patients Taking Aripiprazole on Learning of Vocational Skills

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ClinicalTrials.gov Identifier: NCT00223418
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 8, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Dawn Velligan, The University of Texas Health Science Center at San Antonio

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophenia Disorder Schizoaffective Disorder Drug: aripiprazole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Do Patients Taking Aripiprazole Learn More in Vocational Skills Training Than Patients Taking Olanzapine?
Study Start Date : January 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Toilet Tank Assembly Task at 13 and 14 weeks
  2. Card Sorting Task at baseline, 13 and 14 weeks

Secondary Outcome Measures :
  1. Brief Psychiatric Rating Scale at baseline and 13 week
  2. Negative Symptom Assessment at baseline and 13 week
  3. Global Assessment of Functioning Scale at baseline and 13 week
  4. Social and Occupational Functioning Scale at baseline and 13 week
  5. Work portion of Test of Adaptive Behaviors in Schizophrenia at baseline and 13 week
  6. STAN neurocognitive tests at baseline and 13 week
  7. Trails A at baseline and 13 week
  8. Trails Aa at baseline and 13 week
  9. Trails B at baseline and 13 week


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00223418


Locations
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United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Bristol-Myers Squibb
Investigators
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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
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Responsible Party: Dawn Velligan, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223418    
Other Study ID Numbers: 023-0013-300
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Dawn Velligan, The University of Texas Health Science Center at San Antonio:
aripiprazole
olanzapine
vocational
learning
cognition
cognitive
Additional relevant MeSH terms:
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Disease
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists