Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of
adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of
omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1)
change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the
end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end
of 10-week treatment.
Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant
reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at
the end of treatment compared to placebo.
Phase:
Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
National Center for Complementary and Integrative Health (NCCIH) National Center for Research Resources (NCRR)