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| Descriptive Information Fields | |||||||||
| Brief Title † | Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia | ||||||||
| Official Title † | Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-Episode Schizophrenia | ||||||||
| Brief Summary | This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia. |
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| Detailed Description | Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. People experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. Atypical antipsychotic medications have been shown to produce fewer adverse side effects than older "typical" antipsychotics. Risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia. This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia. Participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection. Participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. Participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks. Dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage. Following 2 to 3 months to achieve outpatient risperidone dosage stabilization, participants will be monitored for 1 year. Study visits will occur once weekly throughout the study. They will include group therapy meetings focused on everyday living skills; family education about schizophrenia; assessments of medication response; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Medication adherence [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Return to work or school (SAS Work Section) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Maintenance of work/school attendance (SAS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Quality of community functioning and interpersonal relatedness (CAF) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Cognitive performance on test battery [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Emotional reactivity on psychophysiological measures [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Retention in treatment [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia | ||||||||
| Intervention † | Behavioral: Group Skills Training and Psychoeducation Behavioral: Individual Case Management Drug: Oral Risperidone Drug: Risperidone in Long-Acting Injectable Form (Consta) |
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| MEDLINE PMIDs | |||||||||
| Links | Click here for the UCLA Center for Neurocognition and Emotion in Schizophrenia website  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 250 | ||||||||
| Start Date † | March 2006 | ||||||||
| Completion Date | March 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00330551 | ||||||||
| Organization ID | P50 MH66286-03 | ||||||||
| Secondary IDs †† | DATR A2-AISZ, Janssen RIS-NAP-4009 | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | January 2008 | ||||||||
| First Received Date † | May 26, 2006 | ||||||||
| Last Updated Date | January 4, 2008 | ||||||||
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