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

NCT00399698 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-06-23

No results posted yet for this study

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).

Conditions

  • Oppositional Defiant Disorder
  • Conduct Disorder
  • Attention Deficit/Hyperactivity Disorder (ADHD)
  • Intermittent Explosive Disorder
  • Impulse-Control Disorders
  • Adjustment Disorder
  • Bipolar Disorder
  • Pervasive Developmental Disorder

Interventions

DRUG

Risperdal

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Michael G Aman, Ph.D. · The Ohio State University Nisonger Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-31
Completion
2005-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399698 on ClinicalTrials.gov