Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
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Purpose
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Behavioral: Group Skills Training and Psychoeducation Behavioral: Individual Case Management Drug: Oral Risperidone Drug: Risperidone in Long-Acting Injectable Form (Consta) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia |
- 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 ]
- 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 ]
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2006 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Long-acting injectible risperidone
Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management
|
Behavioral: Group Skills Training and Psychoeducation
Group skills training sessions will be weekly throughout the study. The sessions 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.
Behavioral: Individual Case Management
An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.
Drug: Risperidone in Long-Acting Injectable Form (Consta)
Participants will take a 25 mg dosage of injectable risperidone once every 2 weeks. Dosage will be adjusted if needed.
Other Name: Risperdal Consta
|
|
Active Comparator: Oral risperidone
Participants taking daily oral risperidone, plus group skills training and case management
|
Behavioral: Group Skills Training and Psychoeducation
Group skills training sessions will be weekly throughout the study. The sessions 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.
Behavioral: Individual Case Management
An individual therapist will provide therapy focused on everyday life skills and aid in interfacing with community agencies, work, and/or school settings.
Drug: Oral Risperidone
Daily oral risperidone dosage will determined by treating psychiatrist.
Other Name: Risperdal
|
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, the randomized medication conditions will begin and 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| Semel Institute for Neuroscience and Human Behavior at UCLA | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | Keith H. Nuechterlein, PhD | University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences |
More Information
Additional Information:
No publications provided by University of California, Los Angeles
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Keith Nuechterlein, Ph.D., Professor, UCLA, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00330551 History of Changes |
| Other Study ID Numbers: | P50 MH066286, P50MH066286, DATR A2-AISZ, Janssen RIS-NAP-4009 |
| Study First Received: | May 26, 2006 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, Los Angeles:
|
Schizoaffective Disorder, Depressed Type Schizophreniform Disorder First-episode Schizophrenia Injectable Risperidone |
Additional relevant MeSH terms:
|
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 June 18, 2013