Fran Lowry

June 26, 2014

HOLLYWOOD, Florida — The combination of high EPA (eicosapentaenoic acid) omega-3 fatty acids and inositol appears to be promising in the treatment of prepubertal children with bipolar spectrum disorders, a pilot study suggests.

The finding, from a preliminary double-blind randomized clinical trial, was presented here at the American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting.

"The possibility of using natural products in the management of a very serious illness like bipolar disorder is extremely important," Joseph Biederman, MD, director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital, Boston, told Medscape Medical News.

"The effects that we saw with these products, particularly the combination of high EPA omega-3 fatty acids plus inositol, were comparable to the effects that we are accustomed to seeing with more toxic drugs. It was quite surprising and quite impressive," Dr. Biederman said.

The small study included 24 children aged 6 to 12 years who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for bipolar spectrum disorder (bipolar disorder I, II, or not otherwise specified [NOS]) and who displayed mixed, manic, or hypomanic symptoms.

Dr. Joseph Biederman

The children were randomly assigned to receive either monotherapy with EPA/DHA (docosahexaenoic acid) omega-3 fatty acids (3000 mg) plus placebo (n = 7), inositol (2000 mg for children weighing 25 kg or more; 80 mg/kg for children weighing less than 25 kg) plus placebo (n = 7), or the combined active treatment of omega-3 fatty acids and inositol (n = 10).

At the end of 12 weeks, the children who received the combined treatment of omega-3 fatty acids and inositol showed significantly greater improvement on the Young Mania Rating Scale (YMRS) than those treated with inositol (P = .021) and omega-3 fatty acids (P = .046) alone.

The combined treatment also had the largest effect size when comparing improvement from baseline to study end with respect to the YMRS (P < .001).

Combination treatment also produced significantly greater improvement in symptoms of depression on the Hamilton Rating Scale for Depression (HAM-D) than monotherapy with inositol or omega-3 fatty acids.

Additionally, combined treatment had the largest effect size when comparing improvement from baseline to study end with respect to the HAM-D scale (P < .001).

The most common adverse event was gastrointestinal problems, reported with omega-3 fatty acids.

"We don't know what the exact mechanism of action is at this point, but inositol works in the cascade of postsynaptic events, and lithium works through affecting the cascade that involves inositol, but exactly how this is beneficial is one of the things that continues to be highly debated for all treatments," Dr. Biederman said.

"The same holds true for omega-3 fatty acids. They are important for the health of the neurons, so we assume that the transmission between the neurons is better if you have something like an omega-3 compound on board. I cannot tell you exactly how these products work, but it is very exciting that we can provide relief in a very serious illness like bipolar disorder," he said.

Medscape Medical News invited Christoph U. Correll, MD, professor of psychiatry and molecular medicine at Hofstra North Shore–LIJ School of Medicine, Glen Oaks, New York, to give his views about this study.

Dr. Christoph Correll

Calling it "an interesting pilot study," Dr. Correll said: "There have been some suggestive data of potential efficacy of omega-3 fatty acid treatment or inositol for mood disorders in adults, but this is the first study to assess monotherapy or combined treatment in a prepubertal sample."

Dr. Correll, who was not part of the study, added that the very low adverse effect risk for the 2 substances "is a potentially relevant benefit, especially in the vulnerable childhood population. While clearly more information is needed, such as how many patients had bipolar disorder I, II, and bipolar disorder NOS, what was the magnitude of the effect sizes, who is likely to benefit the most, etc, the important next step will be to replicate and possibly extend these findings in a much larger sample."

However, he added, "before such data become available, no recommendations for clinical care can be made based on this very small pilot trial that produced early, promising results."

The study was funded by the Massachusetts General Hospital Pediatric Psychopharmacology Council Fund. Dr. Biederman and Dr. Correll reported no relevant financial relationships.

American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting. Abstract 12. Presented June 17, 2014.

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