A prospective open-label trial of quetiapine monotherapy in preschool and school age children with bipolar spectrum disorder

Background: Although bipolar disorder frequently onsets in the preschool years, treatment studies to guide management of these highly dysfunctional children are limited. This study evaluates the response to quetiapine monotherapy in preschool and school age children with bipolar spectrum disorder (BSD). Method: Two eight-week, prospective, open-label trials utilizing identical methodology to assess the effectiveness and tolerability of quetiapine monotherapy in the treatment of BSD in preschool (age 4-6 years) and school age children (age 6-15 years). Results: Forty-nine children (30 preschool and 19 school age) with BSD (Young Mania Rating Scale [YMRS] at entry: 34.5 ± 5.5 and 30 ± 6.5 respectively) were enrolled and 34 (20 preschool and 14 school age) completed the trial. Quetiapine was titrated to a mean endpoint dose of 175.8 ± 63.8 mg/day in preschool and 248.7 ± 153.1 mg/day in school age children. At endpoint, treatment with quetiapine was associated with similar and statistically significant improvement in mean YMRS scores in preschool (- 14.5 ± 11.5, p < 0.001) and school age (- 13 ± 9.8, p < 0.001) children. Quetiapine was generally well tolerated with treatment limiting adverse-events observed in 3/30 preschool and 1/19 school age children. Quetiapine monotherapy in preschool and school age children was associated with significant weight gain (+ 3.1 ± 1.8 and + 7.4 ± 7.7 lb respectively, p < 0.001) and with clinically insignificant changes in vital signs. Limitations: As an uncontrolled study, the assessments were not blind to treatment and the effects of treatment cannot be separated from time. Conclusions: Open-label quetiapine treatment was beneficial for the treatment of BSD in preschool and school age children. Further controlled trials are warranted.