A Phase 2 interventional study of Omega 3 Fatty Acids and Corn oil in Depressive Disorder, Major, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-04-24.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment
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.
This study rests on a confluence of findings showing that: 1) Major depressive disorder (MDD), is a major public health concern that often emerges in adolescence; which entails 2) pathophysiological abnormalities in fronto-striatal structures resulting in death and atrophy of glia and neurons; 3) omega-3 fatty acids (FA) effects on brain function in adolescent MDD can be assessed by proton magnetic resonance spectroscopy (1H MRS); and, 4) it is critical that commonly used complementary and alternative medicines such as omega-3FA that have face validity be tested for their neurobiological effect in MDD.
Using 1H MRSI, this study examines the effects of Omega-3FA on striatal and anterior cingulate cortex (ACC) concentrations of the neurocellular biomarkers total choline (tCho), total creatine (tCr), and γ-aminobutyric acid (GABA, ACC only) in adolescent MDD. Hypotheses are: 1) relative to placebo, omega-3FA treatment will result in significant reductions of striatal and ACC tCho and tCr concentrations, and increased ACC GABA; 2: Regardless of treatment condition (placebo or Omega-3FA), MDD adolescents who are improved at the end of 10-week treatment will exhibit a significant decrease in striatal and ACC tCho and tCr concentrations, and increases in ACC GABA relative to unimproved adolescents.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 16 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion Criteria:
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Dietary Supplement: Corn oil
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
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
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.
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.
Time frame: 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.
Time frame: baseline and 10-weeks
Recruitment began in December 2005, with enrollment from January 2006 to June 2013. Participants recruited for this imaging from another study, GCO 12-1321.
| Milestone | Corn Oil | Omega-3 Fatty Acids |
|---|---|---|
| Started | 7 | 9 |
| Completed | 7 | 9 |
| Not completed | 0 | 0 |
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.
| ratio * 10^-4 | Corn Oil | Omega-3 Fatty Acids |
|---|---|---|
| ACC Glx/Water Baseline | 19.21 ± 5.173 | 18.99 ± 2.989 |
| ACC Glx/Water 10 weeks | 19.28 ± 3.339 | 20.61 ± 5.201 |
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.
| ratio * 10^-4 | Corn Oil | Omega-3 Fatty Acids |
|---|---|---|
| ACC GABA/Water Baseline | 28.37 ± 4.097 | 25.28 ± 2.845 |
| ACC GABA/Water 10 weeks | 28.93 ± 5.200 | 28.84 ± 3.512 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Corn Oil | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Omega-3 Fatty Acids | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Corn Oil | Omega-3 Fatty Acids | Total |
|---|---|---|---|
| Mean | 16.62 ± 3.087 | 16.51 ± 2.756 | 16.56 ± 2.805 |
| Sex: Female, Male(Participants) | Corn Oil | Omega-3 Fatty Acids | Total |
|---|---|---|---|
| Female | 2 | 7 | 9 |
| Male | 5 | 2 | 7 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai