At a glance
ClinicalIndex Comparison Record- ✓DSM-IV diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder for no longer than 3 years after diagnosis
- ✓PANSS score 60–120 at Visit 1 and 2
- ✓Currently on monotherapy atypical antipsychotic below local label guidelines or treatment naive
- ✓In-patients or out-patients
- ✕Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder, or schizoaffective disorder
- ✕Current drug or alcohol dependence
- ✕Depot antipsychotic treatment within 3 months of study start
- ✕Confirmed or suspected history of lack of tolerability, hypersensitivity, or allergy to risperidone
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Randomized Trial Comparing Risperdal Consta With Oral Antipsychotic Care in the Treatment of Early Psychosis
In Brief
A Phase 4 clinical trial evaluating Risperidone long-acting injection (LAI) and Oral Antipsychotic for Schizophrenia and 3 related conditions. Completed, enrolled 77 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).
Study Details
Timeline
Interventions
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion.
Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.