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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148083
First Posted: September 7, 2005
Last Update Posted: March 1, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Janssen, LP
Weill Medical College of Cornell University
Information provided by:
University of Illinois at Chicago
  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
Intervention Model: Factorial Assignment
Masking: Single
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00148083     History of Changes
Other Study ID Numbers: RIS-EMR-4033
2005-04081 (UIC)
First Submitted: September 2, 2005
First Posted: September 7, 2005
Last Update Posted: March 1, 2006
Last Verified: August 2005

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
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