At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Diagnosed with schizophrenia or schizoaffective disorder by structured clinical interview (SCID)
- ✓Recent psychiatric hospitalization (within 2 years) OR current evidence of increased outpatient service use (additional visits, day treatment, medication increases, or new psychotropic agents)
- ✓Able to attend all scheduled visits with transportation available and living within 1.5 hours travel time
- ✕Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days
- ✕Intolerance of risperidone
- ✕Intolerance of intramuscular injection
- ✕Current treatment with depot antipsychotic medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
In Brief
A Phase 3 clinical trial evaluating IM risperidone and oral antipsychotic medication for Schizoaffective Disorder and Schizophrenia. Completed, enrolled 382 participants across 19 sites.
Detailed Summary
In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but not specifying any particular oral agents or dosages). Recruitment would take 27 months to complete, and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited. All patients would be treated from the time of entry up to the end of the three-year study period. Follow-up assessments would continue quarterly. Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration. However, end points will be blindly rated.
Study Details
Timeline
Interventions
long-acting injectable risperidone
doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)