Status:
COMPLETED
Study to Determine Whether There Are Any Cognitive or Motor Effects From Taking the Medicine Risperidone.
Lead Sponsor:
Ohio State University
Conditions:
Oppositional Defiant Disorder
Conduct Disorder
Eligibility:
All Genders
4-14 years
Phase:
PHASE3
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. ...
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, co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00399698
Start Date
May 1 1999
End Date
June 1 2005
Last Update
June 23 2016
Active Locations (1)
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1
Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210