Omega-3 Fatty Acid Monotherapy for Pediatric Bipolar Disorder: A Prospective Open-Label Trial
Amminger GP et al., Biol Psychiatry., 61:551-553,(2007).
Department of Child and Adolescent Neuropsychiatry, Medical Univeristy of Vienna, Vienna, Austria. ORYGEN Research Centre, University of Melbourne, Melbourne, Autstralia
This 8-week study was conducted on 20 children with an average age of 8.7 years (ranging from 6-17 years) who had been diagnosed with a clinically significant manic episode by clinical evaluation and who had YMRS (Young Mania Rating Scale) scores greater than 15. Approximately 2/3 of the subjects met the diagnostic criteria for bipolar I disorder with most of the remaining (25%) fulfilling the criterion for bipolar II disorder. The patients (mixed genders) were obtained from referrals to a pediatric psychopharmacology program at the Massachusetts General Hospital. Treatment with mood stabilizers, anticonvulsants, antidepressants, and neuroleptic pharmacotherapies were not permitted during this study.
The patients received omega-3 fatty acid supplementation beginning with a dose of 3 capsules per day providing a total intake of DHA/EPA combined of 1290 mg/day (165 mg of DHA + 1125 mg of EPA). Following initial dosage with 3 capsules per day, those patients showing no improvement or some worsening in their clinical symptomology based on mania severity scoring were given increased supplementation (increases of up to 3 capsules at a time) to the permitted upper weekly intake of 10 capsules/day (maximum of 4300 mg of DHA/EPA combined per day). Overall, the subjects exhibited a statistically significant improvement in their YMRS scores with an average reduction of 34% (from an average entry YMRS score of 28.9 to an eventual score of 19.1). The adverse effects (some gastrointestinal problems, headache, cold/flu/allergy/infection, plus some others) were considered to be few and mild by the investigators. Since only 35% of the subjects showed a more pronounced response by the use of accepted criterion (> 50% decrease on the YMRS), the researchers conclude that the omega-3 fatty acid treatment as offered was associated with a very modest improvement in manic symptoms in children with BPD (pediatric bipolar disorder).
Dr. Holub's Comments:
Since this open-label and uncontrolled clinical trial indicated some modest benefit in the treatment of children with BPD, these preliminary results should encourage further research using experimental protocols including randomized, double-blinded, crossover trials using varying doses and durations of DHA/EPA in further evaluating the potential benefits of omega-3 supplementation in this patient population. Such studies, if promising, could be of clinical significance considering the morbidity associated with BPD and side effects which are often encountered with various medications used in the treatment of this condition. In addition, the potential use of omega-3 therapeutics as adjunct therapy to the conventional use of medications (and varying doses thereof) would be of interest. Finally, the relative efficacy of DHA versus EPA concentrates and combinations thereof with varying ratios would be of much interest in future controlled clinical trials conducted over different durations.