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

Schizophrenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Schizophrenia

Schizoaffective Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Risperdal Consta (drug)

Behavioral:Social Skills Training

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: September 2005

Completed Date: August 2007

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Scores on an analogue measure of responsiveness to skills training.

Secondary Outcome: Neurocognitive functioning.

Study sponsors, principal investigator, and references

Principal Investigator: Steven M Silverstein, Ph.D.

Lead Sponsor: University of Illinois at Chicago

Collaborator: Janssen, LP

More information:https://clinicaltrials.gov/show/NCT00148083

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