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Double-blind, placebo-controlled trial of clonidine in hyperactive children with mental retardation
V Agarwal1, P Sitholey, S Kumar
1Department of Psychiatry, King George's Medical College, Lucknow (U.P.), India.
Insights
Clonidine medication effectively reduced hyperactivity, impulsivity, and inattention in children with hyperkinetic disorder and intellectual disability. Drowsiness was a common, temporary side effect, indicating clonidine
Area of Science:
- Pediatric Neurology
- Child Psychiatry
- Pharmacology
Background:
- Hyperkinetic disorder (HKD) in children presents significant behavioral challenges.
- Comorbid intellectual disability (ID) complicates treatment of HKD.
- Limited research exists on pharmacotherapy for HKD with comorbid ID.
Purpose of the Study:
- To evaluate the efficacy and safety of oral clonidine in children with HKD and comorbid ID.
- To determine a dose-response relationship for clonidine treatment.
- To assess the impact of clonidine on core symptoms of HKD.
Main Methods:
- A 12-week, double-blind, randomized, placebo-controlled crossover trial.
- Involved 10 children (mean age 7.6 years) with HKD and comorbid ID.
- Clonidine administered in fixed doses (4, 6, 8 mcg/kg/day) with parent and clinician-rated scales.
Main Results:
- A marked, dose-related improvement in hyperactivity, impulsivity, and inattention was observed.
- Parent and clinician ratings confirmed clonidine's effectiveness.
- Drowsiness was the primary side effect, typically resolving within 2-4 weeks.
Conclusions:
- Oral clonidine is a safe and effective treatment option for young children with HKD and comorbid intellectual disability.
- Clonidine demonstrates a beneficial dose-response profile for core HKD symptoms.
- Further research may explore long-term outcomes and optimal dosing strategies.
Abstract:
A 12-week, double-blind, randomized, placebo-controlled trial of oral clonidine in three fixed doses (4, 6, and 8 mcg/kg/day) using a crossover design was conducted with 10 children who had hyperkinetic disorder (mean age 7.6 years +/-.54). All had comorbid mental retardation. Both parents' ratings on the Parent Symptom Questionnaire and clinicians' ratings on the Hillside Behaviour Rating Scale showed a marked dose-related response to clonidine in hyperactivity, impulsivity, and inattention. Drowsiness was a common side effect of clonidine. It wore off by the 2nd to 4th week in most cases. Thus, clonidine is a safe and effective medication in young hyperkinetic children with comorbid mental retardation.