Overview

Effects of Risperdal Consta on Ability to Benefit From Social Skills Training in Schizophrenia

Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
0
Participant gender:
All
Summary
The specific aim of this study is to determine whether the new, long-acting, form of risperidone, Risperdal Consta, improves the ability of schizophrenia patients to benefit from skills training. The hypothesis guiding this study is that Risperdal Consta, by improving verbal memory, will improve the ability to benefit from skills training interventions among schizophrenia patients. The primary objective of this study is to compare patients on Risperdal Consta to patients on other atypical antipsychotic medications in terms of their ability to benefit from skills training interventions. A secondary objective of this study is to determine whether patients taking Risperdal Consta improve in other areas of cognitive functioning and social functioning.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Illinois at Chicago
Collaborators:
Janssen, LP
Weill Medical College of Cornell University
Treatments:
Risperidone
Criteria
Inclusion Criteria:

1. Schizophrenia or schizoaffective disorder

2. Ages 18-55

3. Ability to give informed consent

4. Good general physical health or stable chronic medical conditions

5. Ability to be on a single antipsychotic medication

6. History of inattentiveness in psychosocial treatment settings

7. Poor social skills

8. Must be receiving a single antipsychotic medication

9. Must be clinically stable - defined by the absence of prominent delusions,
hallucinations, disorganized speech, or grossly disorganized or catatonic behavior.
However, there must also be continuing evidence of impairment, as indicated by the
presence of negative symptoms or two or more symptoms of schizophrenia listed in
Criterion A of the DSM-IV, in attenuated form (e.g., odd beliefs, unusual perceptual
experiences).

Exclusion Criteria:

1. Inability to give informed consent

2. Substance dependency in the past 6 months

3. Diagnosis of dementia

4. Significant head injury or other brain injury leading to cognitive impairment

5. Mental retardation (premorbid IQ < 65)

6. Pregnant or nursing

7. Allergy or other significant adverse reaction to risperidone

8. Contraindication to Risperdal Consta as only antipsychotic

9. Currently taking risperidone