Abstract Background: Major depressive disorder (MDD) as one of the disabling mental disorders has turned into one of the significant challenges for health systems worldwide. Although fluoxetine has been successfully applied to over 6-year-old individuals with MDD, its utility for younger patients has not been investigated yet. The current pilot study aims to assess fluoxetine use in 4–6-year-old children diagnosed with MDD. Materials and Methods: The current double-blinded randomized clinical trial has been conducted on 40 four-to-six-year-old children with MDD who were assigned to one of the treatment groups with 0.7 mg/kg daily fluoxetine (n = 20) or placebo (n = 20) for 60 days. Preschool Feelings Checklist-Scale (PFC-S) and the antidepressant side effect checklist (ASEC) were assessed at study initiation, within 30 and 60 days after the intervention. Results: The PFC-S score significantly decreased in the fluoxetine-treated group ( P value < 0.001), while those who received placebo revealed no change ( P value = 0.317). The comparison of fluoxetine versus placebo treatment revealed a remarkable difference between the scores of PFC-S among the groups ( P value < 0.001). Besides, the PFC-S scores were statistically lower among those treated with fluoxetine compared with placebo-treated ones in both 30 days ( P value < 0.001) and 60 days ( P value < 0.001) assessments. None of the patients presented any fluoxetine-related side effect. Conclusion: Based on the findings of this study, fluoxetine was a safe and efficient agent to manage depression in very young children; however, data in this regard are limited and inconclusive. Further studies are strongly recommended.
Shakibaei et al. (Sun,) studied this question.