Objective: The aim of this study was to investigate the efficacy and safety of fluoxetine in the treatment of obsessive-compulsive disorder (OCD) in preschool children.
Method: Six preschool children (age range 40-61 months; mean 51.5 +/- 8.8 months) with severe, distressing symptoms of OCD were treated with an initial 5 mg/day oral dose of fluoxetine by mouth. Baseline and end-point symptom severity was assessed using the Clinical Global Impressions-Severity (CGI-S) scale. The data for this study were collected by reviewing medical records of the subjects.
Results: CGI-S baseline scores were 6-7 (mean 6.66 +/- 0.5) and end-point scores were 3-7 (mean 4 +/- 1.54). The Wilcoxon nonparametric paired t-test revealed a significant difference between baseline and end-point CGI-S scores (Z = -2.121; p = 0.034). The range of fluoxetine dosage was 5-15 mg/day (mean 10 +/- 3.16). Fluoxetine was effective in treating OCD in this sample. Four subjects showed much and 1 subject showed very much improvement in OCD symptoms. One subject, who discontinued medication after 4 weeks due to side effects, did not show any improvement with 5 mg/day fluoxetine. Two subjects developed significant symptoms of behavioral disinhibition (SBD) that required dose reduction and addition of 0.25-0.5 mg/day risperidone in 1 subject and discontinuation of medication in the second subject. Side effects were mild to moderate in severity and did not require medication discontinuation or dosage reduction in the remaining three subjects. One subject did not report any side effects. Overall the most frequently reported side effects were SBD, decreased appetite and weight loss (n = 3; range: 0-1200 grams; mean, 466 +/- 546.5 grams), sleep disturbance, headache, and abdominal pain.
Conclusions: Fluoxetine may be effective in the treatment of OCD in preschool children. However side effects, particularly SBD, remain an important concern.