Omega-3 Fatty Acids in Adolescent Depression
Completed · Phase 2 · Has a placebo group
Conditions studied: Adolescent Depression
In brief
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.
Key facts
- Study ID
- NCT00312897
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 57
- Starts
- 2005-12-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2018-04-19
Who can join
Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 12-19
- Depressed with DSM-IV diagnosis of MDD
- Duration of depressive episode greater than 6 weeks
You may not qualify if…
- 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
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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