Childhood depression warrants treatment research; including pharmacological and
psychotherapeutic interventions. A recent study found fluoxetine to be the only medication
with empirical support for decreasing depression in children, but concerns about
treatment-emergent suicidal ideation/behavior led the FDA to mandate black-box warning for
use of antidepressants in this age group (Bridge et al, 2007). These worries have prompted
interest in alternative therapies including dietary supplements such as omega-3 fatty acids
(Ω3).
The current study compares Ω3, psychoeducational psychotherapy (PEP), and their combination
to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with
unipolar depression. Primary goals are to determine: 1) feasibility of a) recruiting 60
participants in 24 months; b) retaining participants over a 12-week trial; and 2) effect
sizes for Ω3, PEP, and combination treatment. Secondary goals are to explore response curves
over time, mediators and moderators, treatment response across an array of outcome variables,
adherence to treatment, and side effects. This pilot study of Ω3, PEP, and combined treatment
will provide evidence about whether a larger trial is feasible and justifiable.