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Published on: November 21, 2013
Evaluating movement disorders in pediatric patients receiving risperidone: a comparison of spontaneous reports and
Gahan J Pandina1, Cynthia A Bossie, Young Zhu
1Ortho-McNeil Janssen Scientific Affairs, L.L.C., Titusville, NJ, USA. gpandina@prdus.jnj.com
Background:
Movement disorders (MD) in children are relatively common and may be associated with medication use. Objective methods (ie rating scales) and specific research criteria may be helpful in identifying MD-related adverse events that would otherwise not be apparent from spontaneous reports. We assessed whether more stringent and rigorous criteria would provide MD rates similar to those derived subjectively from spontaneous reports.
Methods:
MDs were assessed in children with disruptive behavior disorders (DBDs) and subaverage intelligence receiving risperidone. Data were from three 1-year, open-label studies in subjects 4-14 years old. Dyskinesia severity was rated by the Extrapyramidal Symptom Rating Scale (ESRS) dyskinesia subscale. Tardive dyskinesia (TD) was defined: mild dyskinesia (scores 2, 3) in two anatomical areas; or moderate dyskinesia (score >or= 4) in one area for >or= 4 weeks in subjects without dyskinesia at baseline (scores 0, 1).
Results:
The mean (+/- SD) age of subjects was 9.4 +/- 2.4 years, the mean (+/- SD) risperidone dose was 1.6 +/- 0.7 mg/day, and the mean (+/- SD) exposure was 317.8 +/- 104.5 days. ESRS data were available for 668 subjects. Mean ESRS scores were low throughout the study. At baseline, 655 subjects had no dyskinetic symptoms. One subject met predefined TD criteria after a risperidone dose reduction. Symptoms persisted for 4 weeks, resolving with continued treatment and no dosage change. Two different subjects had TD by spontaneous adverse-event reports, with dyskinetic symptoms at 1-2 visits, and symptoms that resolved after treatment discontinuation. Thirteen subjects had dyskinesia at baseline; their mean ESRS dyskinesia scores decreased at endpoint.
Conclusion:
Using objective rating scales and research criteria, low-dose risperidone was associated with low risk of TD and other MDs in children with DBDs in three large 1-year studies. Careful, objective evaluation of emergent MDs during all stages of treatment is essential for identifying treatment-emergent TD.
Insights
Low-dose risperidone showed a low risk of movement disorders (MD) and tardive dyskinesia (TD) in children with disruptive behavior disorders. Objective assessments confirmed these findings across three large studies.
Area of Science:
- Pediatric neurology
- Psychopharmacology
- Clinical research methodology
Background:
- Movement disorders (MD) are common in children and can be linked to medication use.
- Objective methods like rating scales and specific criteria aid in identifying drug-induced MDs.
- This study evaluated if rigorous criteria yield MD rates comparable to subjective reports.
Purpose of the Study:
- To assess the incidence of movement disorders (MD), specifically tardive dyskinesia (TD), in children with disruptive behavior disorders (DBDs) treated with risperidone.
- To compare MD rates derived from objective rating scales and research criteria versus spontaneous adverse event reports.
- To evaluate the safety and tolerability of low-dose risperidone in this pediatric population.
Main Methods:
- Three 1-year, open-label studies included children aged 4-14 with DBDs receiving risperidone.
- Dyskinesia severity was measured using the Extrapyramidal Symptom Rating Scale (ESRS) dyskinesia subscale.
- Tardive dyskinesia (TD) was defined using specific criteria based on dyskinesia severity, affected areas, and duration, excluding baseline symptoms.
Main Results:
- The study included 668 subjects with a mean age of 9.4 years, treated with a mean risperidone dose of 1.6 mg/day.
- Most subjects (655/668) had no dyskinetic symptoms at baseline; only one subject met TD criteria after a dose reduction, with symptoms resolving.
- Spontaneous reports identified TD in two subjects, with symptoms resolving after treatment discontinuation; baseline dyskinesia scores decreased by study end.
Conclusions:
- Low-dose risperidone was associated with a low risk of TD and other MDs in children with DBDs, as confirmed by objective measures.
- Rigorous, objective evaluation of emergent MDs throughout treatment is crucial for accurate identification of treatment-emergent TD.
- The findings support the safety profile of risperidone for managing DBDs in children when carefully monitored.
