At a glance
ClinicalIndex Comparison Record- ✓Age 12–19 years
- ✓DSM-IV diagnosis of major depressive disorder (MDD)
- ✓Current depressive episode lasting >6 weeks
- ✕Current or past DSM-IV-TR bipolar disorder, schizophrenia, psychosis, PDD, or Tourette's disorder
- ✕Current or past eating, panic, conduct, OCD, PTSD, or substance-related disorders (except nicotine)
- ✕Current suicidal ideation with intent or plan, or danger to self
- ✕Antidepressant use within 60 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Omega-3 Fatty Acids in Adolescent Depression
In Brief
A Phase 2 clinical trial evaluating Omega-3 Fatty Acids and corn oil for Adolescent Depression. Completed, enrolled 57 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
10 wk treatment period
placebo comparator