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

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ClinicalTrials.gov Identifier: NCT00399698
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Aman, Ohio State University

Tracking Information
First Submitted Date  ICMJE November 13, 2006
First Posted Date  ICMJE November 15, 2006
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE May 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2006)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00399698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine Whether There Are Any Cognitive or Motor Effects From Taking the Medicine Risperidone.
Official Title  ICMJE Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children
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 (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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE
  • Oppositional Defiant Disorder
  • Conduct Disorder
  • Attention Deficit/Hyperactivity Disorder (ADHD)
  • Intermittent Explosive Disorder
  • Impulse-Control Disorders
  • Adjustment Disorder
  • Bipolar Disorder
  • Pervasive Developmental Disorder
Intervention  ICMJE Drug: Risperdal
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 13, 2006)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00399698
Other Study ID Numbers  ICMJE 1998H0298
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Aman, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael G Aman, Ph.D. The Ohio State University Nisonger Center
PRS Account Ohio State University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP