Study to Determine Whether There Are Any Cognitive or Motor Effects From Taking the Medicine Risperidone.
Condition: Oppositional Defiant Disorder; Conduct Disorder; Attention Deficit/Hyperactivity Disorder (ADHD); Intermittent Explosive Disorder; Impulse-Control Disorders; Adjustment Disorder; Bipolar Disorder; Pervasive Developmental Disorder
MeSH terms: Bipolar Disorder; Attention Deficit Disorder with Hyperactivity; Developmental Disabilities; Conduct Disorder; Autism Spectrum Disorder; Attention Deficit and Disruptive Behavior Disorders; Adjustment Disorders; Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Risperdal
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Severe conduct problems; Risperidone; Risperdal