Omega-3 Fatty Acids in Adolescent Depression

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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)

Criteria

Inclusion Criteria:

• Age: 12-19

• Depressed with DSM-IV diagnosis of MDD

• Duration of depressive episode greater than 6 weeks

Exclusion Criteria:

• Current or past DSM-IV-TR bipolar, schizophrenia, psychosis, pervasive developmental disorder (PDD), and Tourette's disorder.

• Current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic stress, and/or substance-related disorders (other than nicotine).

• Adolescents who present with current suicidal ideation with intent or plan, or who may pose a danger to themselves.

• Current antidepressant treatment, or taken within 60 days prior to enrollment

• Neuroleptics taken within 90 days prior to enrollment