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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Risperidone

Criteria

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.