Optimizing Response in Psychosis Study — ORP  

Schizophrenia Clinical Trial

Official title: Optimizing Response in Psychosis Study

Status Terminated

Clinical Trial Summary

The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial.

Clinical Trial Description

The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic, risperidone, for the treatment of first episode patients who fail to respond to 12 weeks of treatment with an oral antipsychotic. The rationale for using this long-acting medication is that it eliminates covert non-adherence, which may be a factor in poor response. In addition, pharmacokinetic and pharmacodynamic differences between injectable and oral formulations may result in differences in treatment response favoring the injectable form. Subjects who have not responded sufficiently to treatment with an antipsychotic will be approached for the proposed long-acting risperidone trial. Risperidone treatment will be open label with titration based upon individual response (within FDA approved dose ranges). Treatment will begin with a phase of supplementation with oral risperidone. Subjects will stop their previous antipsychotic, start 2 mg of oral risperidone per day for one day and then increase the dose to 4 mg per day. Subjects who tolerate one week of oral risperidone will then begin injections of 25 mg long-acting risperidone every 2 weeks for a total of 12 weeks. If clinically indicated, the dose may be increased up to a maximum of 50 mg as per FDA guidelines. ;

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychotic Disorder Not Otherwise Specified
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

• NCT number: NCT00314327
• Study type: Interventional
• Source: Northwell Health
• Status: Terminated
• Phase: Phase 4
• Start date: April 2006
• Completion date: November 2013