Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Oral Risperidone; Drug: Risperidone in Long-Acting Injectable Form (Consta)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00330551

Janssen RIS-NAP-4009 (Other Grant/Funding Number)

P50MH066286 (U.S. NIH Grant/Contract)

DATR A2-AISZ

Details and patient eligibility

About

This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Long-acting injectible risperidone

Experimental group

Description:

Participants who are randomly assigned to this arm will be administered the long-acting injectible form of risperidone (Risperdal Consta) every two weeks, plus group skills training and case management, for 12 months.

Treatment:

Drug: Risperidone in Long-Acting Injectable Form (Consta)

Oral risperidone

Active Comparator group

Description:

Participants who are randomly assigned to this arm will be treated with the oral version of risperidone (Risperdal) daily, plus group skills training and case management, for 12 months.

Treatment:

Drug: Oral Risperidone