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Executive Summary

FDA WILL FUND LITHIUM AND PHENYTOIN STUDIES to assess the drugs' efficacy in the treatment of patients "who manifest episodes of extreme violence and aggressiveness," the agency announced in a notice published in the Aug. 10 Federal Register. FDA plans to award $250,000 for one or two studies through its Orphan Products Development office, with additional funding available for up to three years, according to the notice. The agency notes that "there is some evidence that certain patients who exhibit extreme aggressiveness and perpetuate acts of violent nature toward people and/or property improve when they receive" the drugs, but that "there are few controlled studies" in such patients "because of the difficulty of performing meaningful studies." FDA specifically wants a randomized double-blind placebo controlled study to determine "whether, in nonpsychotic, nonepileptic adult patients who commit frequent acts of violence toward property and/or people, phenytoin and lithium are more effective than placebo in reducing the number and severity of such acts." The agency also advises that "if feasible, the study should also attempt to discern whether one drug is more effective than the other and what types of patients are more likely to respond." The agency further suggests that an in-patient trial may provide more reliable reporting than one involving out-patients. "Paramount to the success of the study is the ability to assure reliable reporting of violent acts and their nature" the notice states. "Therefore, it is important to consider whether the study would be more appropriately performed in an inpatient rather than an outpatient setting." Application kits for the grants are available from Kathryn McKnight of the agency's Grants and Assistance Agreements Section, HFA-522, FDA, 5600 Fishers Lane, Rockville, Md. 20857, (301) 443-6170.

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