drugset / Trial / NCT00790075
Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children
NaSingle-groupOpen-labelTreatment
Summary
The goal of this study is to demonstrate safety and efficacy of liquid risperidone in psychiatrically hospitalized children, ages 4-12, who would be put in seclusion or restraint, or given an intramuscular injection of diphenhydramine because of their out-of-control behavior if not medicated with risperidone. The first part of the study will: 1) develop appropriate oral doses of medication to reduce out of control or agitated behavior effectively with the fewest side effects, and 2) develop a rating system to measure the children's behavior i.e. level of improvement, sedation, and untoward effects.
Timeline
- Start
- 2003-01
- Primary completion
- 2004-06
- Completion
- 2004-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 0.015 mg/kg | Oral |
| Subject | Risperidone | Other / unclassified | 0.02 mg/kg | Oral |
| Subject | Risperidone | Other / unclassified | 0.025 mg/kg | Oral |
| Subject | Risperidone | Other / unclassified | 0.3 mg/kg | Oral |
Indications
No indication recorded.