Clinical trial NCT00223418: Study Comparing Patients Taking Olanzapine and Patients Taking Aripiprazole on Learning of Vocational Skills
Official title: Do Patients Taking Aripiprazole Learn More in Vocational Skills Training Than Patients Taking Olanzapine?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophenia Disorder
Schizoaffective Disorder
Keywords: aripiprazole
olanzapine
vocational
learning
cognition
cognitive
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility 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

Primary outcomes:
measure: Toilet Tank Assembly Task at 13 and 14 weeks
measure: Card Sorting Task at baseline, 13 and 14 weeks
Secondary outcomes:
measure: Brief Psychiatric Rating Scale at baseline and 13 week
measure: Negative Symptom Assessment at baseline and 13 week
measure: Global Assessment of Functioning Scale at baseline and 13 week
measure: Social and Occupational Functioning Scale at baseline and 13 week
measure: Work portion of Test of Adaptive Behaviors in Schizophrenia at baseline and 13 week
measure: STAN neurocognitive tests at baseline and 13 week
measure: Trails A at baseline and 13 week
measure: Trails Aa at baseline and 13 week
measure: Trails B at baseline and 13 week
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center in San Antonio
name: Dawn I Velligan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Mary D. Woolsey, M.S.
role: STUDY_DIRECTOR
References: