| May 26, 2006 |
| June 10, 2009 |
| March 2006 |
| March 2011 (final data collection date for 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 ]
|
- Measured over 12 months: Medication adherence
- Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)
- Return to work or school (SAS Work Section)
- Maintenance of work/school attendance (SAS)
- Quality of community functioning and interpersonal relatedness (CAF)
|
| Complete list of historical versions of study NCT00330551 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Measured over 12 months: Cognitive performance on test battery
- Emotional reactivity on psychophysiological measures
- Retention in treatment
- Awareness of illness, as assessed by the Scale to Assess Unawareness of Mental Disorder, Revised Version (SUMD-R)
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| |
| Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia |
| Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-Episode Schizophrenia |
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Schizophrenia |
- Behavioral: Group Skills Training and Psychoeducation
- Behavioral: Individual Case Management
- Drug: Oral Risperidone
- Drug: Risperidone in Long-Acting Injectable Form (Consta)
|
- Experimental: Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management
- Active Comparator: Participants taking daily oral risperidone, plus group skills training and case management
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| |
| |
| Recruiting |
| 250 |
| March 2011 |
| March 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder
- First major episode of psychotic symptoms occurred within 2 years prior to study entry
- Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia
Exclusion Criteria:
- Neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury)
- Mental retardation (e.g., premorbid IQ less than 70)
- Significant alcohol or substance abuse within 6 months prior to study entry
- Inability to complete research measures in English
- Any condition that may make risperidone use medically inadvisable
|
| Both |
| 18 Years to 45 Years |
| Yes |
|
|
| United States |
| |
| NCT00330551 |
| Keith H. Nuechterlein, PhD, UCLA |
| P50 MH66286, DATR A2-AISZ, Janssen RIS-NAP-4009 |
| National Institute of Mental Health (NIMH) |
| Ortho-McNeil Janssen Scientific Affairs, LLC |
| Principal Investigator: |
Keith H. Nuechterlein, PhD |
University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences |
|
|
| National Institute of Mental Health (NIMH) |
| June 2009 |