Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia

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.

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