NCT00065273

Brief Summary

Psychiatric drugs are often used to treat behavioral symptoms of mental retardation/developmental delay (MR/DD). These drugs can cause serious side effects. Newer drugs may have decreased side effects. This study will compare new and old drugs used to treat behavioral symptoms in people with MR/DD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 1998

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2003

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2003

First QC Date

July 21, 2003

Last Update Submit

June 23, 2005

Conditions

Mental RetardationDevelopmental Delay Disorder

Keywords

Severe aberrant behaviorRisperidoneClozapineHaloperidolLaboratory operant tasksSimple acquisition proceduresMatching to sample taskLag sequential analysis

Interventions

risperidoneDRUG
clozapineDRUG
olanzapineDRUG

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary diagnosis of mental retardation (IQ \< 70)
  • Scheduled for medication reductions from psychotropic drugs and subsequent placement on risperidone
  • Severe self-injury, aggression, property destruction, or stereotypic behavior for 6 months prior to study entry
  • No seizures, or seizures under control of medication for previous 2 years
  • Participants in the primary study who are available for 2 hour weekly or bi-weekly clinic visits and are able to have observers in their home, school, and/or work environment

You may not qualify if:

  • Degenerative disease that may affect motor or cognitive functioning
  • Progressive disease of an organ system
  • Advanced age that may produce deteriorating cognitive or motor functioning
  • Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (5)

  • Valdovinos MG, Napolitano DA, Zarcone JR, Hellings JA, Williams DC, Schroeder SR. Multimodal evaluation of risperidone for destructive behavior: functional analysis, direct observations, rating scales, and psychiatric impressions. Exp Clin Psychopharmacol. 2002 Aug;10(3):268-75. doi: 10.1037//1064-1297.10.3.268.

    PMID: 12233987BACKGROUND

  • McAdam DB, Zarcone JR, Hellings J, Napolitano DA, Schroeder SR. Effects of risperidone on aberrant behavior in persons with developmental disabilities: II. Social validity measures. Am J Ment Retard. 2002 Jul;107(4):261-9. doi: 10.1352/0895-8017(2002)1072.0.CO;2.

    PMID: 12069645BACKGROUND

  • Zarcone JR, Hellings JA, Crandall K, Reese RM, Marquis J, Fleming K, Shores R, Williams D, Schroeder SR. Effects of risperidone on aberrant behavior of persons with developmental disabilities: I. A double-blind crossover study using multiple measures. Am J Ment Retard. 2001 Nov;106(6):525-38. doi: 10.1352/0895-8017(2001)1062.0.CO;2.

    PMID: 11708938BACKGROUND

  • Hellings JA, Zarcone JR, Crandall K, Wallace D, Schroeder SR. Weight gain in a controlled study of risperidone in children, adolescents and adults with mental retardation and autism. J Child Adolesc Psychopharmacol. 2001 Fall;11(3):229-38. doi: 10.1089/10445460152595559.

    PMID: 11642473BACKGROUND

  • Hammock R, Levine WR, Schroeder SR. Brief report: effects of clozapine on self-injurious behavior of two risperidone nonresponders with mental retardation. J Autism Dev Disord. 2001 Feb;31(1):109-13. doi: 10.1023/a:1005626100084.

    PMID: 11439749BACKGROUND

MeSH Terms

Conditions

Intellectual DisabilityDevelopmental Disabilities

Interventions

RisperidoneClozapineOlanzapine

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Stephen Schroeder, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

July 21, 2003

First Posted

July 22, 2003

Study Start

July 1, 1998

Study Completion

June 1, 2001

Last Updated

June 24, 2005

Record last verified: 2003-06

Locations

US(1)