Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder

OBJECTIVE: To test the efficacy of riluzole in youth with bipolar disorder STUDY POPULATION: Youth, ages 9-17, with DSM-IV bipolar disorder, who have failed to respond to two adequate trials of medication, one with an atypical antipsychotic medication, and the second with either a mood stabilizing medication or a second atypical antipsychotic medication. DESIGN: Medication withdrawal, followed by a 15-day dose stabilization phase and a 6-week double-blind, placebo-controlled treatment trial. The first two phases will be completed as inpatients or in day treatment, while the third phase can be completed either in those settings or as an outpatient. Individuals who received placebo will be offered an 8-week open trial of riluzole followed by an additional 4 weeks if they respond, while those who received riluzole in the placebo-controlled trial and wish to continue it will receive 4 weeks of open treatment. Thus, all patients will have the opportunity to receive a total of 12 weeks of riluzole treatment. OUTCOME MEASURES: Clinical rating scales, including the Pediatric Anxiety Rating Scale and the Clinical Global Improvement Scale