This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Adolescent depression is common, and the recent fears of SSRI toxicities, such as suicidal ideation, make it logical to look for other treatment modalities. Epidemiological and neurobiological studies have shown positive effects of omega-3 fatty acids (omega-3FA) in major depressive order (MDD) and a number of clinical studies have also demonstrated a significant effect. However, there have been no relevant clinical trials of omega-3FA in adolescent MDD. This is a preliminary exploratory study in adolescents with MDD.
The aim i s 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. The investigators hypothesize that 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. Forty 12-18 year olds with depression for >8 weeks and a severity score of >40 on the CDRS-r will be recruited. They will be randomized to treatment and placebo. Treatment will begin with 2 weeks of a low dose (1.8 g/d) of the drug and, if no improvement is seen, will increase by 0.6 g/d increments for additional 2-week intervals, with a maximal dose of 3.6 g/d, amounting to 6 capsules. Baseline and subsequent weekly psychological assessment tools will be used to assess efficacy and safety.
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