The Role Of Omega-3 Fatty Acids In Adolescent Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT00962598

Run by

Icahn School of Medicine at Mount Sinai

People needed

16

Starts

2006-01-01

Expected to finish

2013-06-01

Last updated by the study team

2018-04-24

Who can join

Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.
• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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