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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of Illinois at Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Janssen, LP
Weill Medical College of Cornell University
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00148083
First received: September 2, 2005
Last updated: February 27, 2006
Last verified: August 2005
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00148083

Contacts
Contact: Steven M Silverstein, Ph.D. (312) 996-9515 ssilverstein@psych.uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Steven M Silverstein, Ph.D.    312-996-9515    ssilverstein@psych.uic.edu   
Contact: Sarah Berten, B.A.    (312) 355-4901    sberten@psych.uic.edu   
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    ads9002@med.cornell.edu   
Principal Investigator: Adam Savitz, M.D., Ph.D.         
Sponsors and Collaborators
University of Illinois at Chicago
Janssen, LP
Weill Medical College of Cornell University
Investigators
Principal Investigator: Steven M Silverstein, Ph.D. University of Illinois at Chicago
  More Information

No publications provided

ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Schizophrenia
Cognition
Clinical Trial

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014