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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00330551 |
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia |
Behavioral: Group Skills Training and Psychoeducation Behavioral: Individual Case Management Drug: Oral Risperidone Drug: Risperidone in Long-Acting Injectable Form (Consta) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-Episode Schizophrenia |
Estimated Enrollment: | 250 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management
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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.
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2: Active Comparator
Participants taking daily oral risperidone, plus group skills training and case management
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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.
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rosemary Collier, MS | 310-206-3142 | rcollier@mednet.ucla.edu |
Contact: Luana Turner, PsyD | 310-206-3142 | luana@ucla.edu |
United States, California | |
Semel Institute for Neuroscience and Human Behavior at UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Principal Investigator: Keith H. Nuechterlein, PhD | |
Sub-Investigator: Kenneth L. Subotnik, PhD |
Principal Investigator: | Keith H. Nuechterlein, PhD | University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences |
Responsible Party: | UCLA ( Keith H. Nuechterlein, PhD ) |
Study ID Numbers: | P50 MH66286-03, DATR A2-AISZ, Janssen RIS-NAP-4009 |
Study First Received: | May 26, 2006 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00330551 |
Health Authority: | United States: Federal Government |
Schizoaffective Disorder, Depressed Type Schizophreniform Disorder First-episode Schizophrenia Injectable Risperidone |
Schizophrenia Dopamine Depression Mental Disorders |
Risperidone Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |