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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


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 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)

Secondary outcome:

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)

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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


- Participant in the UCLA Center for Neurocognition and Emotion in Schizophrenia

Exclusion Criteria:

- Neurological disorder or injury (e. g., encephalitis, epilepsy, traumatic brain


- 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

Page last updated: August 23, 2015

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