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.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Illinois
Collaborators:
Janssen, LP
Weill Medical College of Cornell University
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT00148083
First received: September 2, 2005
Last updated: February 27, 2006
Last verified: August 2005
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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:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by University of Illinois:
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:
- 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).
Exclusion Criteria:
- 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
Contacts and Locations
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
Janssen, LP
Weill Medical College of Cornell University
Investigators
| Principal Investigator: | Steven M Silverstein, Ph.D. | University of Illinois |
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:
|
Schizophrenia Cognition Clinical Trial |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013