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Oppositional Defiant DisorderPhase 3NCT00399698

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

A Phase 3 study testing Risperdal in people with Oppositional Defiant Disorder and Conduct Disorder, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 14 years
What is being tested?
Risperdal
How many people
30 participants
Where
1 siteUnited States
Study dates
May 1999to Jun 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ohio State University Nisonger Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children

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).
Read the detailed description

Antipsychotics are fairly commonly used for managing certain psychiatric disorders that occur in childhood: schizophrenia, autistic disorder, delusional manic depressive disorder, bipolar disorder, conduct disorder, and disruptive behavior associated with mental retardation (Botteron \& Geller, 1998). They are also occasionally used for ADHD when more conventional treatments, such as psychostimulants and tricyclic antidepressants, have failed (Botteron \& Geller, 1998). Despite a helpful role for the antipsychotic medications in many childhood conditions, there is a persistent although poorly substantiated impression that these medicines cause "cognitive blunting" in children. This may be more commonly heard than seen in print, but we believe that it is the cause of considerable resistance to antipsychotic treatment by physicians and nonmedical professionals alike.

At the same time, the data supporting the notion of cognitive blunting by antipsychotic medicines is largely negative (although limited in amount) and frequently badly out of date (see Ernst, Malone, Rowan, George, Gonzales, \& Silva, 1998; Aman, 1984; Aman, Marks, Turbott, Wilsher, \& Merry, 1991). There are good theoretical reasons to believe that novel antipsychotics may have no effects on cognition or may actually enhance cognitive functioning, at least in some disorders (Borison, 1996; Meltzer, 1995; Stip, 1996). At least one study thus far has shown significantly improved cognitive performance in schizophrenic patients taking risperidone as compared with such patients taking high-potency classical antipsychotics or no treatment (Gallhofer, Bauer, Lis, Krieger, \& Gruppe, 1996).

Another source of resistance to the use of antipsychotic medicines with young people is the possibility that they may cause tardive dyskinesia. However, available data on the novel antipsychotics suggests that they are substantially safer than classical antipsychotics in this respect. Nevertheless, data are limited because of the newness of agents like risperidone.

Our laboratory at O.S.U. is unique because it has a sophisticated computer-controlled cognitive-motor test battery. O.S.U. is one of seven universities supported by NIMH as part of its network of Research Units on Pediatric Psychopharmacology ("RUPPs"). Recently, Dr. Mike Aman reviewed the available cognitive test systems on behalf of the Autism RUPP Group. From this exercise, it became quite clear to us that we maintain what is probably the world's best system for assessing the cognitive-motor effects of psychotropic drugs in children, especially children with developmental handicaps.

The experimental (research) portion of the treatment is to assess the effects of risperidone (Risperdal) on learning performance and motor movements in children. This study is looking at whether or not risperidone improves performance on certain cognitive-motor tasks. It is also looking to detect any negative side effects that the medicine has on children's body movements. Risperidone is often used to treat children with disruptive behaviors. This study will involve 18-20 children who are being treated by their own physicians with risperidone (for duration of 4 months or longer) for such behavior problems.

Being tested
Risperdal
Keywords
Severe conduct problems, Risperidone, Risperdal
Medical subject headings
Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit Disorder with Hyperactivity, Disruptive, Impulse Control, and Conduct Disorders, Adjustment Disorders, Bipolar Disorder, Child Development Disorders, Pervasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisperdalDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Term Recognition Memory task (accuracy)

  2. Titrated Delayed Matching-to-Sample task (accuracy)

  3. Continuous Performance task (omission errors)

  4. Seat Activity

  5. Graduated Holes task (errors and error times)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2006 (estimated)
  2. Study startMay 1999
  3. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00399698
Sponsor's protocol ID
1998H0298
Status last verified
Jun 2016
First submitted
13 Nov 2006
Last updated
23 Jun 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risperdal in people with Oppositional Defiant Disorder and Conduct Disorder, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Term Recognition Memory task (accuracy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.

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