Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399698
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2006-11-13
Brief Title:
Study to Determine Whether There Are Any Cognitive or Motor Effects From Taking the Medicine Risperidone
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 ie there will be no unmasking of tardive dyskinesia
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 ie 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 OSU is unique because it has a sophisticated computer-controlled cognitive-motor test battery OSU 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 worlds 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 childrens 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
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 OSU is unique because it has a sophisticated computer-controlled cognitive-motor test battery OSU 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 worlds 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 childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None