Omega-3 Fatty Acids in Adolescent Depression

NCT00312897 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GCO# 12-1321R21AT002395-01A2
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Depression

Keywords

Adolescents; Depression; Fish Oil; Omega-3 Fatty Acids; Psychiatry

Outcome Measures

Primary Outcomes (1)

• Children's Depressive Rating Scale - Revised (CDRS-R)

  It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).

  baseline and 10-weeks

Secondary Outcomes (1)

• Clinician's Global Improvement Scale (CGI)

  baseline and 10-week treatment phase

Study Arms (2)

corn oil

PLACEBO COMPARATOR

as stated

Drug: corn oil

Omega 3 Fatty Acids

EXPERIMENTAL

as stated

Drug: Omega-3 Fatty Acids

Interventions

Omega-3 Fatty Acids DRUG

10 wk treatment period

Also known as: fish oil

Omega 3 Fatty Acids

corn oil DRUG

placebo comparator

corn oil

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Fatty Acids, Omega-3; Fish Oils; Corn Oil

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Vilma Gabbay
• Organization: Icahn School of Medicine at Mount Sinai

vilma.gabbay@mssm.edu

212-659-1661

Study Officials

• Vilma Gabbay, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2006
• First Posted: April 11, 2006
• Study Start: December 1, 2005
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 19, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-03

Locations

US (1)