The Role Of Omega-3 Fatty Acids In Adolescent Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Omega 3 Fatty Acids; Corn oil
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Adolescents; Major Depressive Disorder; Proton Magnetic Resonance Spectroscopy; Immune System Activation; Omega-3 Fatty Acids

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 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.

          -  Female subjects who are sexually active and not using a method of birth control will
             be excluded. Use of hormonal contraceptives (such as prescribed "birth control pills"
             or a prescribed birth control implant) is not exclusionary.

          -  Subjects must be able to swallow capsules.

          -  A minimum IQ of 80 will be required.

        Exclusion Criteria:

          -  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.

          -  Current antidepressant treatment will be excluded. Past antidepressant treatment will
             not be exclusionary, so long as patients are off antidepressant medication for 60 days
             prior to study entry. No individual will be advised to terminate ongoing treatment.

          -  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.

          -  A minimum of 90 days off of treatment with long half life medications, such as
             neuroleptics, prior to study entry is required. Stimulant medication treatment for
             ADHD will not be exclusionary.

          -  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.