High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone

Schizophrenia Clinical Trial

Official title: High Dose Risperidone Consta for Patients With Schizophrenia With Unsatisfactory Response to Standard Dose Risperidone or Long-Acting Injectable

Status Completed

Clinical Trial 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.

Clinical Trial Description

This six month double-blind,randomized trial is designed to compare the efficacy of high dose long acting risperidone ( 75 mg-100 mg q2 weeks or its equivalent) with standard doses of long acting risperidone (≤50 mg/q 2weeks) for Total Psychopathology, positive, negative, and depressive symptoms, and cognition in patients who are considered to be poor responders by themselves, significant others, or clinicians. This will include two types of inadequately responding patients—those who are treatment resistant by research criteria (Kane et al., 1988) and those with inadequate response ;

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

• NCT number: NCT00539071
• Study type: Interventional
• Source: Northwestern University
• Status: Completed
• Phase: Phase 4
• Start date: March 2008
• Completion date: May 2012