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

NCT00148083 | Completed Phase 3

• 2 other identifiers: RIS-EMR-40332005-04081 (UIC)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Cognition; Clinical Trial

Outcome Measures

Primary Outcomes (3)

• Scores on an analogue measure of responsiveness to skills training.

• Scores on a measure of skills acquisition and performance pre-post a 3-month skills training group.

• Interview measures of social functioning.

Secondary Outcomes (2)

• Neurocognitive functioning.

• Symptomatology.

Interventions

Risperdal Consta (drug) DRUG

Social Skills Training BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Schizophrenia or schizoaffective disorder
• Ages 18-55
• Ability to give informed consent
• Good general physical health or stable chronic medical conditions
• Ability to be on a single antipsychotic medication
• History of inattentiveness in psychosocial treatment settings
• Poor social skills
• Must be receiving a single antipsychotic medication
• 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).

You may not qualify if:

• Inability to give informed consent
• Substance dependency in the past 6 months
• Diagnosis of dementia
• Significant head injury or other brain injury leading to cognitive impairment
• Mental retardation (premorbid IQ \< 65)
• Pregnant or nursing
• Allergy or other significant adverse reaction to risperidone
• Contraindication to Risperdal Consta as only antipsychotic
• Currently taking risperidone

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Janssen, LP: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

New York Presbyterian Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Steven M Silverstein, Ph.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: September 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

US (2)