NCT00399698

Brief 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. 1.Risperidone will have no adverse effects on cognitive-motor performance in children who have received maintenance therapy for 4 to 20 months.
  2. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 1999

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

First QC Date

November 13, 2006

Last Update Submit

June 21, 2016

Conditions

Oppositional Defiant DisorderConduct DisorderAttention Deficit/Hyperactivity Disorder (ADHD)Intermittent Explosive DisorderImpulse-Control DisordersAdjustment DisorderBipolar DisorderPervasive Developmental Disorder

Keywords

Severe conduct problemsRisperidoneRisperdal

Outcome Measures

Primary Outcomes (5)

  • Short Term Recognition Memory task (accuracy)

  • Titrated Delayed Matching-to-Sample task (accuracy)

  • Continuous Performance task (omission errors)

  • Seat Activity

  • Graduated Holes task (errors and error times)

Interventions

RisperdalDRUG

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 4 to 14 years, inclusive
  • Male or female gender
  • Reason for receiving risperidone must include severe conduct problems
  • Received risperidone treatment for at least 4 months
  • Dosage in the range of 0.01 to 0.099 mg/kg/day
  • Capable of discontinuing risperidone for up to 14 days in the judgement of child's physician
  • Taking co-therapy with psychostimulants, antihistamines, melatonin, and chloral hydrate is allowed as long as co-therapy is held constant
  • Taking co-therapy for sleep with guanfacine hydrochloride, clonidine hydrochloride, and trazodone hydrochloride is allowed so long as co-therapy is held constant
  • Must have a reliable adult carer who can report on subject's behavior and attend scheduled assessments
  • Parent or guardian must give informed consent, and subject must give assent if 14 years of age or older
  • Must be considered physically healthy on the basis of physical exam and medical history.

You may not qualify if:

  • Patients who meet DSM-IV criteria for schizophrenia, schizophreniform disorder, dissociative disorder, major depression, schizoaffective disorder, substance induced psychotic disorder
  • Subjects who are pregnant
  • Subjects with known seizure disorder
  • Subjects with a history of neuroleptic malignant syndrome
  • Subjects with a known or suspected history of severe drug allergy or hypersensitivity
  • Subjects must have no significant medical disease
  • Subjects must not be taking any other psychotropic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Nisonger Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Oppositional Defiant DisorderConduct DisorderAttention Deficit Disorder with HyperactivityDisruptive, Impulse Control, and Conduct DisordersAdjustment DisordersBipolar DisorderChild Development Disorders, Pervasive

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersTrauma and Stressor Related DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael G Aman, Ph.D.

    The Ohio State University Nisonger Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus of Psychology

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 15, 2006

Study Start

May 1, 1999

Study Completion

June 1, 2005

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

US(1)