TITLE:
The Efficacy of Fluoxetine in Treating Depression in Children under 13: A Literature Review
AUTHORS:
Elowyn M’Cloud, Rima Azar
KEYWORDS:
Fluoxetine, Pediatric Depression, Selective Serotonin Reuptake Inhibitors, Children, Major Depressive Disorder
JOURNAL NAME:
Open Journal of Medical Psychology,
Vol.15 No.4,
October
15,
2026
ABSTRACT: Introduction: Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), is widely used to treat depression and is FDA-approved for major depressive disorder in children aged 8 - 18 years. However, pediatric regulatory status differs by jurisdiction, and evidence regarding its efficacy and safety specifically in children under 13 remains limited. Objective: This review examined fluoxetine’s effectiveness and safety for treating depression in children under 13. Methods: A literature review was conducted using PsycInfo and PubMed, focusing on studies from 2000-2020. Eight articles met predefined inclusion and exclusion criteria, analyzing fluoxetine’s impact on pediatric depression. Results: Studies used varied methodologies, complicating direct comparisons. However, key findings emerged: fluoxetine showed modest efficacy in reducing depressive symptoms, although evidence specifically for children under 13 remained limited and inconclusive. Evidence from broader pediatric antidepressant studies also identified an increased risk of suicide-related outcomes, emphasizing the importance of careful monitoring. Reported side effects included behavioural activation and mood instability. Data on long-term remission and safety were insufficient for clear treatment guidelines. Conclusion: Fluoxetine may offer short-term benefits for pediatric depression, but evidence specific to children under 13 remains limited. Treatment decisions for younger children should follow applicable clinical guidelines and involve careful assessment and monitoring. Further research is necessary to clarify long-term effects and refine treatment strategies for younger children.