Phase 2 N=51 Randomized Quadruple-blind Treatment

Omega-3 Fatty Acids in Adolescent Depression

Adolescent Depression

Bottom Line

View on ClinicalTrials.gov: NCT00312897 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Children's Depressive Rating Scale - Revised (CDRS-R) — 50.2; 49.5; 35.2; 36.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Omega-3 Fatty Acids (Drug); corn oil (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Children's Depressive Rating Scale - Revised (CDRS-R)	50.2; 49.5; 35.2; 36.5	—
SECONDARY Clinician's Global Improvement Scale (CGI)	4.0; 4.0; 3.2; 3.4	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00312897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.