ω-3 Fatty Acids in Pediatric Major Depressive Disorder: A Randomized Clinical Trial
Abstract
IMPORTANCE: Meta-analyses of ω-3 fatty acids for depression have reported inconsistent results, and pediatric evidence is sparse. Promotion of unproven supplements may delay evidence-based care.
OBJECTIVE: To evaluate whether adjunctive ω-3 fatty acid supplementation improves outcomes in moderate-to-severe pediatric major depressive disorder (MDD).
DESIGN, SETTING, AND PARTICIPANTS: In a multicenter, double-blind, placebo-controlled randomized clinical trial at 5 Swiss child and adolescent psychiatry centers, 257 youths with MDD were enrolled and randomized between April 28, 2017, and March 24, 2022, and followed up for 36 weeks, with final analysis from July 1, 2022, to January 26, 2023. Analysis was based on intention to treat.
INTERVENTIONS: Participants received ω-3 fatty acids, 1.5 g/d (1 g of eicosapentaenoic acid [EPA] and 0.5 g of docosahexaenoic acid [DHA], 2:1 ratio), or medium-chain triglyceride placebo in combination with standardized psychotherapy. Antidepressant use was permitted per national guidelines.
MAIN OUTCOMES AND MEASURES: The primary outcome was the trajectory of Children's Depression Rating Scale-Revised (CDRS-R) scores analyzed with a joint mixed-effects and time-to-event model accounting for dropout or initiation of off-trial antidepressant therapy. Secondary outcomes included response (≥30% reduction in CDRS-R scores), remission (CDRS-R score ≤28), self-rated depression, quality of life, suicidality, and safety.
RESULTS: Of 257 randomized…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 257 participants or records.
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