Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania

Summary

The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient more or less likely to develop mania (i.e. periods of irritability or extreme silliness accompanied by decreased need for sleep, risky behaviors, feeling like the patient has special abilities, inability to sit still, and rapid speech) in the future. Yet another purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3 fatty acids are not United States Food and Drug Administration (FDA)-approved to treat depression in adults or in children and adolescents.

Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea foods, though they are also found in other food sources such as flax seed. Omega-3 fatty acids have been shown to play a role in affecting brain chemicals responsible for regulating mood and have been found to reduce symptoms of depression in medicated-patients with major depressive disorder.

By completing this study, the investigators hope to better understand who benefits from treatment, why they do or do not respond to medications, and who is at greater risk for developing further mental illness. With this information, the investigators hope to be able to improve treatment and outcome in people with major depressive disorder.

Conditions

• Mania

Interventions

DRUG

OMega 3

Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day

DRUG

Placebo

Placebo given twice a day which will be compared to Omega 3

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Cincinnati

  lead OTHER

Principal Investigators

• Melissa DelBello, MD · University of Cincinnati

• Robert McNamara, PhD · University of Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• United States

Study Locations