Clinical Trial: Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children

Brief 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.

Detailed Summary:

A. Develop an appropriate dose structure for risperidone. Children needing oral medication will be initially offered a safe minimal dose (0.015 mg/kg) dose of risperidone (between 0.3 and 0.6mg for children weighing between 20-40kg). If there is no response, or an inadequate response (anything less than "much improved" on the Clinical Global Improvement Scale) after 30 minutes, the next dose (0.02 mg/kg) will be used if there is another occasion to use a medication intervention the following day. Similarly, a medium dose (0.025 mg/kg) dose will be used if the lower dose is inadequate. The highest dose is 0.3mg/kg. For a big child (we have had children who weigh as much as 55kg this would work out to a maximum dose of 1.6 mg/dose, well within the dose range administered on a one time, daily basis to children (2 mg is the usual maximum, though a daily dose of 3-4 mg is not uncommon). If the child is already receiving risperidone, total daily dose will not exceed 0.07mg/kg/day (the maximum dose used in the RUPP trial). Weight dose chart follows on the next page. Intervention following the 30 minutes will depend on clinical judgement. It may include a different medication, open seclusion, or room restriction.

B. Develop a rating instrument for the stages of agitation needing to be rated. It has been difficult to operationalize when to intervene, and how to rate improvement. There are absolutely no guidelines on this. We have developed a list of behaviors that a nurse rater will use to observe the child at 5, 15, 30, 45, 60, 90 and 120 minutes after any intervention for an episode of agitation. We will, of course, be specifically interested in these measures for children receiving risperidone. (It maybe necessary to videotape some children to develop reliability on the measure.) The advantage of using such an instrument will be that the children will be very closely
Sponsor: Stony Brook University

Current Primary Outcome: reduced time to end of agitation episode compared to unmedicated agitation episode [ Time Frame: Duration of "time out" or time in seclusion ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stony Brook University

Dates:
Date Received: November 12, 2008
Date Started: January 2003
Date Completion:
Last Updated: November 12, 2008
Last Verified: November 2008