Harvard Researchers Show Specially Formulated High EPA Omega-3 Supplement Effective as a Stand-Alone Treatment for Children with Bipolar Disorder, ADD.

* Researchers Used OmegaBrite[TM] Omega-3 to Reduce Mood Symptoms with No Side Effects

BOSTON -- A recently published study by researchers at Harvard's Massachusetts General Hospital shows that a specially formulated high EPA Omega-3 fatty acid supplement should be the first-line treatment for children with ADD, ADHD, bipolar disorder, and other educational and behavioral problems. The OmegaBrite[TM] supplement of Omega-3 fatty acids was tested for effectiveness and safety on 20 boys and girls with bipolar disorder, 6 to 17 years old, over an eight-week period. Half of these participants experienced a rapid 30 percent reduction in symptoms with no side effects.

"Results from this prospective, open study of monotherapy with Omega-3 fatty acids in the over-the-counter product OmegaBrite suggest that manic symptoms can be rapidly reduced in youths with BPD with a safe and well-tolerated nutritional supplement," concluded the study authored by Dr. Janet Wozniak. The Massachusetts General study, funded by a Stanley Foundation grant, was reported in European Neuropsychopharmacology in February 2007.

"What this study shows is that every child with ADD, bipolar or any other mood disorder should be on OmegaBrite," said Dr. John Ratey, author of the best-selling Driven to Distraction and one of the foremost experts on ADD. "And the only side effect is a longer life."

"This is great news for parents," said Dr. Carol Locke, a graduate of Harvard Medical School, who served on the faculty for 14 years before creating OmegaBrite. "Parents are always struggling with how best to help their children. It is incredibly gratifying to develop a product that offers a safe mood stabilizer and natural anti-depressant."

The Mass General study showed that OmegaBrite supplements reduced the participating children's Young Mania Rating Scale Scores (YMRS) by 30 percent. This is the standard rating scale for children with bipolar disorder. The same Mass General research team in 2005 conducted a similar study with risperidone or olanzapine, the two most commonly prescribed drugs for the disorder. OmegaBrite was on a par with olanzapine, which reduced symptoms by 30 percent in 53 percent of the participating children, while risperidone helped 69 percent achieve this result. However, these drugs have numerous and serious side effects such as diabetes, as well as causing weight gain, acne and other conditions that can affect children's self esteem, said Dr. Locke.

Other agents in use such as lithium, divalproex and carbamazepine are only minimally effective or fraught with adverse effects, the researchers noted.

This new Harvard study on OmegaBrite adds to the results of a 2005 double blind study from the University of Oxford. This three-month study of 117 children from 5 to 12 years old with ADHD demonstrated improvements in motor skills, literacy skills, and teacher-rated behavioral and learning difficulties among the participants taking high EPA Omega-3s. Those taking a placebo had no noticeable behavior or learning improvements.

Following Dr. Andrew Stoll's discovery that Omega-3 fatty acids were a treatment for bipolar disorder in adults, Dr. Locke foresaw the need for a high concentrate EPA Omega-3 fatty acid and developed OmegaBrite to bring to the public the first high concentrate EPA Omega-3 manufactured to a pharmaceutical grade of purity. OmegaBrite provides 90 percent pure Omega-3, making it three times more potent than the most common fish oil supplements.

"EPA and DHA are essential fatty acids that the body cannot make so we must obtain them in our diet, which is very hard to do, or by supplements," said Dr. Locke. "An imbalance of Omega-6 and Omega-3 can result in an overall inflammatory response and related disorders such as depression, cardiac disease, cancer, dementia, asthma and rheumatoid arthritis."

Research on Omega-3 is exploding, with 6,900 articles in the Medline database. Research in this week's issue of The Lancet showed that people with high cholesterol levels and taking statins reduced their frequency of major cardiac events by about 20 percent when supplemented with the high EPA Omega-3. The Japan EPA Lipid Intervention Study (JELIS) followed 18,645 Japanese patients who were given Omega-3 supplements for 4 1/2 years.

"The Harvard Pediatric Bipolar study and the JELIS study demonstrate the power of the Omega-3 EPA on mood and cardiac health," Dr. Locke concluded. "Over the next five years, we will see Omega-3 fatty acids become a foundation of health."

For more information, www.omegabrite.com.

Sources:

Eur Neuropsychopharmacol. 2007 Jan 25; (Epub ahead of print)
"Omega-3 fatty acid monotherapy for pediatric bipolar disorder:
A prospective open-label trial.

The Lancet
31 March 2007; "Effects of eicosapentaenoic acid on major coronary
events in hypercholesterolaemic patients (JELIS): a
randomized open-label, blinded endpoint analysis"