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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Toilet Tank Assembly Task at 13 and 14 weeks
Card Sorting Task at baseline, 13 and 14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Brief Psychiatric Rating Scale at baseline and 13 week
Negative Symptom Assessment at baseline and 13 week
Global Assessment of Functioning Scale at baseline and 13 week
Social and Occupational Functioning Scale at baseline and 13 week
Work portion of Test of Adaptive Behaviors in Schizophrenia at baseline and 13 week
STAN neurocognitive tests at baseline and 13 week
Trails A at baseline and 13 week
Trails Aa at baseline and 13 week
Trails B at baseline and 13 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center at San Antonio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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