At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of schizophrenia or schizoaffective disorder (DSM-IV)
- ✓Currently on oral risperidone ≤6 mg, olanzapine ≤20 mg, or conventional neuroleptic at haloperidol-equivalent ≤10 mg daily
- ✓Clinically stable on current medication for ≥4 weeks but with suboptimal response (inadequate symptom control or tolerability)
- ✕Any DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder
- ✕Currently treated with antipsychotics other than oral risperidone, olanzapine, or conventional oral neuroleptics
- ✕Known hypersensitivity to risperidone, quetiapine, aripiprazole, or prior failure of ≥2 antipsychotic agents
- ✕Mood stabilizers or antidepressants not at stable dose for ≥3 months prior to study start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness
In Brief
A Phase 3 clinical trial evaluating Aripiprazole, Risperidone Long Acting Injectable (LAI), and 1 other intervention for Schizophrenia and Psychotic Disorders. Completed, enrolled 753 participants across 96 sites in 24 countries.
Detailed Summary
The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.
Study Details
Timeline
Interventions
10-30 mg oral once daily for 104 weeks
25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective.
Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg.