Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Group Skills Training and Psychoeducation (Behavioral); Individual Case Management (Behavioral); Oral Risperidone (Drug); Risperidone in Long-Acting Injectable Form (Consta) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of California, Los Angeles Official(s) and/or principal investigator(s): Keith H. Nuechterlein, PhD, Principal Investigator, Affiliation: University of California, Los Angeles, Department of Psychiatry and Biobehavioral Sciences
Summary
This study will determine the effectiveness of oral risperidone versus long-acting
injectable risperidone in treating people with first-episode schizophrenia.
Clinical Details
Official title: Effects of Risperdal Consta Versus Oral Antipsychotic Medication on Clinical and Functional Outcome and Neurocognition in First-episode Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Medication adherenceExacerbation 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)
Secondary outcome: Cognitive performance on test batteryEmotional 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)
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, California 90095, United States
Additional Information
Click here for the UCLA Center for Neurocognition and Emotion in Schizophrenia website
Starting date: March 2006
Last updated: November 2, 2013
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