drugset / Trial / NCT00399698

Study to Determine Whether There Are Any Cognitive or Motor Effects From Taking the Medicine Risperidone.

NCT00399698

Phase 3 Completed 30 enrolled Ohio State University
RandomizedCrossoverDouble-blindDiagnostic

Summary

This study was developed in order to assess the effects of risperidone (Risperdal) as compared with placebo on cognitive-motor performance (attention, memory, and hand steadiness) and body movements. We propose to study the effects of risperidone on cognitive-motor performance in children already medicated for severe conduct problems. We would also like to look at safety by assessing these children for dyskinetic movements. We already have a sizable cohort of children maintained on risperidone. Our hypotheses are as follows: 1. Risperidone will have no adverse effects on cognitive-motor performance in children who have received maintenance therapy for 4 to 20 months. 2. Children tested during placebo will show no more dyskinetic movements than during risperidone treatment (i.e., there will be no unmasking of tardive dyskinesia).

Timeline

Start
1999-05
Primary completion
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified