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

Completed · Phase 3

Conditions studied: Oppositional Defiant Disorder, Conduct Disorder, Attention Deficit/Hyperactivity Disorder (ADHD), Intermittent Explosive Disorder, Impulse-Control Disorders, Adjustment Disorder, Bipolar Disorder, Pervasive Developmental Disorder

In brief

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).

Key facts

Study ID

NCT00399698

Run by

Ohio State University

People needed

30

Starts

1999-05-01

Expected to finish

2005-06-01

Last updated by the study team

2016-06-23

Who can join

Age: 4 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ohio State University Nisonger Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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