The Role Of Omega-3 Fatty Acids In Adolescent Depression

NCT00962598 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GCO 12-1321R21AT004576-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton magnetic resonance imaging.

Conditions

Depressive Disorder, Major

Keywords

Adolescents; Major Depressive Disorder; Proton Magnetic Resonance Spectroscopy; Immune System Activation; Omega-3 Fatty Acids

Outcome Measures

Primary Outcomes (2)

• ACC Glx/Water

  The data reflects the ratio of Glutamine-Glutamate and water in the brain (ratio divided by 10000 for analysis purposes). Glutamate is a precursor to Glutamine, an amino acid which functions as an excitatory neurotransmitter in the human brain.

  baseline and 10-weeks

• ACC GABA/Water

  The ratio of gamma-Aminobutyric acid (GABA) and water in the brain (ratio divided by 10000 for analysis purposes), that was observed in MR Spectroscopy. GABA, an amino acid produced by cells of the central nervous system, is an inhibitory neurotransmitter, prominent in the human brain.

  baseline and 10-weeks

Study Arms (2)

Corn Oil

PLACEBO COMPARATOR

The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.

Dietary Supplement: Corn oil

Omega-3 Fatty Acids

EXPERIMENTAL

The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.

Drug: Omega 3 Fatty Acids

Interventions

Omega 3 Fatty Acids DRUG

The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.

Also known as: Fish oil

Omega-3 Fatty Acids

Corn oil DIETARY_SUPPLEMENT

The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.

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:

• to 19 years old (inclusive) of both sexes and all ethnic/racial groups.
• DSM-IV-TR criteria for MDD
• MDD Duration of at least 8 weeks and a severity score of at least 40 on the CDRS-R.
• Age at first onset MDD of at least 12 years.
• No significant medical or neurological disorder
• For female subjects, negative pregnancy test at time of enrollment.
• Subjects must be able to swallow capsules.
• A minimum IQ of 80 will be required.

You may not qualify if:

• Current or Past DSM-IV-TR diagnoses of bipolar disorder, schizophrenia, psychosis, autism/pervasive developmental disorder (PDD), and Tourette's disorder (TD).
• Current diagnosis of eating disorder, panic disorder, obsessive-compulsive disorder (OCD), post traumatic stress disorder (PTSD), conduct disorder, and substance related disorders other than nicotine.
• Current suicidal ideation with intent or plan, or who may pose a danger to themselves.
• Certain short half-life medications, such as vitamins that contain unidentified ingredients, St. Johns Wort, S-adenosyl Methionine (SAM), clonidine, and some over-the-counter medications.
• If adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. However, psychotherapy cannot be initiated at the time of study entry.

Sponsors & Collaborators

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

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Gabbay V, Freed RD, Alonso CM, Senger S, Stadterman J, Davison BA, Klein RG. A Double-Blind Placebo-Controlled Trial of Omega-3 Fatty Acids as a Monotherapy for Adolescent Depression. J Clin Psychiatry. 2018 Jun 26;79(4):17m11596. doi: 10.4088/JCP.17m11596.

  PMID: 29985566 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

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

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

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: August 19, 2009
• First Posted: August 20, 2009
• Study Start: January 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 24, 2018
• Results First Posted: May 24, 2017

Record last verified: 2018-04

Locations

US (1)