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Fluoxetine Use for Very Young Children with Major Depression Disorder: A Pilot Randomized Clinical Trial
Fereshteh Shakibaei1, Mahdieh Soltanian1, Alireza Abdellahi2
1Associated Professor, Child and Adolescent Psychiatrist, Behavioral Sciences Research Center, Psychiatry Department, Medical School, Isfahan University of Medical Sciences, Isfahan, Iran.
Insights
Fluoxetine effectively reduced depression symptoms in 4-6-year-olds with major depressive disorder (MDD) and was well-tolerated. This pilot study suggests fluoxetine
Area of Science:
- Pediatric Psychiatry
- Clinical Psychology
- Pharmacology
Background:
- Major depressive disorder (MDD) presents a significant global health challenge.
- Fluoxetine is approved for MDD in individuals over six, but its efficacy in younger children remains unexplored.
- This pilot study investigates fluoxetine's use in 4-6-year-old children with MDD.
Purpose of the Study:
- To evaluate the safety and efficacy of fluoxetine in treating major depressive disorder (MDD) in very young children aged 4-6 years.
- To compare fluoxetine's effects against a placebo in this pediatric population.
- To assess the incidence of side effects associated with fluoxetine treatment in young children.
Main Methods:
- A double-blind, randomized clinical trial involving 40 children aged 4-6 with MDD.
- Participants received either 0.7 mg/kg daily fluoxetine (n=20) or a placebo (n=20) for 60 days.
- The Preschool Feelings Checklist-Scale (PFC-S) and Antidepressant Side Effect Checklist (ASEC) were used for assessments.
Main Results:
- Fluoxetine treatment led to a significant decrease in PFC-S scores (P < 0.001), unlike the placebo group (P = 0.317).
- A significant difference in PFC-S scores was observed between the fluoxetine and placebo groups (P < 0.001) at both 30 and 60 days.
- No fluoxetine-related side effects were reported by any participants.
Conclusions:
- Fluoxetine appears to be a safe and effective treatment for depression in very young children (4-6 years).
- The findings suggest potential for fluoxetine in managing early-onset pediatric depression.
- Further research is recommended due to limited data and the need for conclusive evidence.
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.
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