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.
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
- Conditions the study is for
- Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit/Hyperactivity Disorder (ADHD)
- 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
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:
- Risperidone will have no adverse effects on cognitive-motor performance in children who have received maintenance therapy for 4 to 20 months.
- 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.
- Conditions
- Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit/Hyperactivity Disorder (ADHD), Intermittent Explosive Disorder, Impulse-Control Disorders, Adjustment Disorder
- 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.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startMay 1999
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oppositional Defiant DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Aman, Ohio State University
- Investigators
- Michael G Aman, Ph.D., Principal investigator, The Ohio State University Nisonger Center
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children
- ClinicalTrials.gov ID
- NCT00399698
- Acronym / sponsor ID
- 1998H0298
- Conditions
- Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit/Hyperactivity Disorder (ADHD), Intermittent Explosive Disorder, Impulse-Control Disorders, Adjustment Disorder
- Keywords
- Severe conduct problems, Risperidone, Risperdal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- May 1999
- Study completion
- Jun 2005
- First posted
- 15 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Risperidone will have no adverse effects on cognitive-motor performance in children who have received maintenance therapy for 4 to 20 months.
- Children tested during placebo will show no more dyskinetic movements than during risperidone treatment (i.e., there will be no unmasking of tardive dyskinesia).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperdal | Drug | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G Aman, Ph.D. principal investigator
The Ohio State University Nisonger Center
1 site in 1 country: see every site and its status.
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.