Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2011

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants taking risperidone, administered in injectible long-acting form (Risperdal Consta), plus group skills training and case management
• Active Comparator: 2
  • Participants taking daily oral risperidone, plus group skills training and case management

Primary Measures

• Medication adherence
  • Time Frame: Measured at Month 12
    Safety Issue?: No
• Exacerbation or relapse of psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS)
  • Time Frame: Measured at Month 12
    Safety Issue?: No
• Return to work or school (SAS Work Section)
  • Time Frame: Measured at Month 12
    Safety Issue?: No
• Maintenance of work/school attendance (SAS)
  • Time Frame: Measured at Month 12
    Safety Issue?: No
• Quality of community functioning and interpersonal relatedness (CAF)
  • Time Frame: Measured at Month 12
    Safety Issue?: No

Secondary Measures

• Cognitive performance on test battery
  • Time Frame: Measured at Month 12
    Safety Issue?: No
• Emotional reactivity on psychophysiological measures
  • Time Frame: Measured at Month 12
    Safety Issue?: No
• Retention in treatment
  • Time Frame: Measured at Month 12
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Keith H. Nuechterlein, PhD Principal Investigator University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences  

Overall Contact: Rosemary Collier, MS 310-206-3142 rcollier@mednet.ucla.edu

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00330551

Study ID Number: P50 MH66286-03

ClinicalTrials.gov Identifier: NCT00330551

Health Authority: United States: Federal Government

Click here for the UCLA Center for Neurocognition and Emotion in Schizophrenia website