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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by University of Illinois at Chicago.
Recruitment status was:  Recruiting
Janssen, LP
Weill Medical College of Cornell University
Information provided by:
University of Illinois at Chicago Identifier:
First received: September 2, 2005
Last updated: February 27, 2006
Last verified: August 2005
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.

Condition Intervention Phase
Schizoaffective Disorder
Drug: Risperdal Consta (drug)
Behavioral: Social Skills Training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy of Risperidone Consta for Improving Ability to Benefit From Skills Training in Schizophrenia

Resource links provided by NLM:

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Neurocognitive functioning.
  • Symptomatology.

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: August 2007
  Show Detailed Description


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00148083

Contact: Steven M Silverstein, Ph.D. (312) 996-9515

United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Steven M Silverstein, Ph.D.    312-996-9515   
Contact: Sarah Berten, B.A.    (312) 355-4901   
Principal Investigator: Steven M Silverstein, Ph.D.         
United States, New York
New York Presbyterian Hospital Not yet recruiting
White Plains, New York, United States, 10605
Contact: Adam Savitz, M.D., Ph.D.    914-997-4394   
Principal Investigator: Adam Savitz, M.D., Ph.D.         
Sponsors and Collaborators
University of Illinois at Chicago
Janssen, LP
Weill Medical College of Cornell University
Principal Investigator: Steven M Silverstein, Ph.D. University of Illinois at Chicago
  More Information Identifier: NCT00148083     History of Changes
Other Study ID Numbers: RIS-EMR-4033
2005-04081 (UIC)
Study First Received: September 2, 2005
Last Updated: February 27, 2006

Keywords provided by University of Illinois at Chicago:
Clinical Trial

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents processed this record on May 25, 2017