At a glance
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High Dose Risperidone Consta for Patients With Schizophrenia With Unsatisfactory Response to Standard Dose Risperidone or Long-Acting Injectable
In Brief
A Phase 4 clinical trial evaluating long-acting injectable risperidone, long acting injectable risperidone, Conventional Dose Group, and 1 other intervention for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 160 participants across 1 site.
Detailed Summary
The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schizophrenia or schizoaffective disorder.
Study Details
Timeline
Interventions
Subjects will be randomized to conventional dose Consta or high dose Consta. All of those who are randomized to the conventional Consta dose will receive it in the form of Consta at a starting dose of 50 mg q 2 weeks. Those who are randomized to high dose Consta will receive a Consta 50 mg injection plus 25 mg injection (total dose 75 mg) q 2 weeks as the starting dose.Oral risperidone will be given up to Week 4 along with the injections for both groups to provide a transition phase.At Week 6, psychopathology will be assessed with a PANSS. If no improvement from baseline is shown, the randomized dose of Consta will be increased to 100 mg q 2 weeks (given as two 50 mg injections ) for those in the high dose Consta group. The dose for those randomized to the conventional dose group will remain the same (50 mg plus placebo).
Study dose remains 50 mg for the length of the study.
Beginning dose 75 mg. Can be increased to 100 mg at Week 6.