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

NCT00223418 | Completed

• 1 other identifier: 023-0013-300
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophenia Disorder; Schizoaffective Disorder

Keywords

aripiprazole; olanzapine; vocational; learning; cognition; cognitive

Outcome Measures

Primary Outcomes (2)

• Toilet Tank Assembly Task at 13 and 14 weeks

• Card Sorting Task at baseline, 13 and 14 weeks

Secondary Outcomes (9)

• 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

Interventions

aripiprazole DRUG

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dawn I Velligan, Ph.D.

  University of Texas Health Science Center in San Antonio

  PRINCIPAL INVESTIGATOR

• Mary D. Woolsey, M.S.

  The University of Texas Health Science Center at San Antonio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

US (1)