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A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study.
J Clin Psychiatry. 2015 Nov; 76(11):1548-55.JC

Abstract

OBJECTIVE

We conducted a 12-week, randomized, double-blind, controlled clinical trial to evaluate the effectiveness and tolerability of high eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) omega-3 fatty acids and inositol as monotherapy and in combination in children with bipolar spectrum disorders.

METHOD

Participants were children 5-12 years of age meeting DSM-IV diagnostic criteria for bipolar spectrum disorders (bipolar I or II disorder or bipolar disorder not otherwise specified [NOS]) and displaying mixed, manic, or hypomanic symptoms. Subjects with severe illness were excluded. Subjects were randomized to 1 of 3 treatment arms: inositol plus placebo, omega-3 fatty acids plus placebo, and the combined active treatment of omega-3 fatty acids plus inositol. Data were collected from February 2012 to November 2013.

RESULTS

Twenty-four subjects were exposed to treatment (≥ 1 week of study completed) (inositol [n = 7], omega-3 fatty acids [n = 7], and omega-3 fatty acids plus inositol [n =10]). Fifty-four percent of the subjects completed the study. Subjects randomized to the omega-3 fatty acids plus inositol arm had the largest score decrease comparing improvement from baseline to end point with respect to the Young Mania Rating Scale (P < .05). Similar results were found for the Children's Depression Rating Scale (P < .05) and the Brief Psychiatric Rating Scale (P <.05).

CONCLUSION

Results of this pilot randomized, double-blind, controlled trial suggest that the combined treatment of omega-3 fatty acids plus inositol reduced symptoms of mania and depression in prepubertal children with mild to moderate bipolar spectrum disorders. Results should be interpreted in light of limitations, which include exclusion of severely ill subjects, 54% completion rate, and small sample size.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01396486.

Authors+Show Affiliations

Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Boston. Harvard Medical School, Boston, Massachusetts.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26646031

Citation

Wozniak, Janet, et al. "A Randomized Clinical Trial of High Eicosapentaenoic Acid Omega-3 Fatty Acids and Inositol as Monotherapy and in Combination in the Treatment of Pediatric Bipolar Spectrum Disorders: a Pilot Study." The Journal of Clinical Psychiatry, vol. 76, no. 11, 2015, pp. 1548-55.
Wozniak J, Faraone SV, Chan J, et al. A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study. J Clin Psychiatry. 2015;76(11):1548-55.
Wozniak, J., Faraone, S. V., Chan, J., Tarko, L., Hernandez, M., Davis, J., Woodworth, K. Y., & Biederman, J. (2015). A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study. The Journal of Clinical Psychiatry, 76(11), 1548-55. https://doi.org/10.4088/JCP.14m09267
Wozniak J, et al. A Randomized Clinical Trial of High Eicosapentaenoic Acid Omega-3 Fatty Acids and Inositol as Monotherapy and in Combination in the Treatment of Pediatric Bipolar Spectrum Disorders: a Pilot Study. J Clin Psychiatry. 2015;76(11):1548-55. PubMed PMID: 26646031.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study. AU - Wozniak,Janet, AU - Faraone,Stephen V, AU - Chan,James, AU - Tarko,Laura, AU - Hernandez,Mariely, AU - Davis,Jacqueline, AU - Woodworth,K Yvonne, AU - Biederman,Joseph, PY - 2014/05/23/received PY - 2015/02/11/accepted PY - 2015/12/10/entrez PY - 2015/12/10/pubmed PY - 2016/3/30/medline SP - 1548 EP - 55 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 76 IS - 11 N2 - OBJECTIVE: We conducted a 12-week, randomized, double-blind, controlled clinical trial to evaluate the effectiveness and tolerability of high eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) omega-3 fatty acids and inositol as monotherapy and in combination in children with bipolar spectrum disorders. METHOD: Participants were children 5-12 years of age meeting DSM-IV diagnostic criteria for bipolar spectrum disorders (bipolar I or II disorder or bipolar disorder not otherwise specified [NOS]) and displaying mixed, manic, or hypomanic symptoms. Subjects with severe illness were excluded. Subjects were randomized to 1 of 3 treatment arms: inositol plus placebo, omega-3 fatty acids plus placebo, and the combined active treatment of omega-3 fatty acids plus inositol. Data were collected from February 2012 to November 2013. RESULTS: Twenty-four subjects were exposed to treatment (≥ 1 week of study completed) (inositol [n = 7], omega-3 fatty acids [n = 7], and omega-3 fatty acids plus inositol [n =10]). Fifty-four percent of the subjects completed the study. Subjects randomized to the omega-3 fatty acids plus inositol arm had the largest score decrease comparing improvement from baseline to end point with respect to the Young Mania Rating Scale (P < .05). Similar results were found for the Children's Depression Rating Scale (P < .05) and the Brief Psychiatric Rating Scale (P <.05). CONCLUSION: Results of this pilot randomized, double-blind, controlled trial suggest that the combined treatment of omega-3 fatty acids plus inositol reduced symptoms of mania and depression in prepubertal children with mild to moderate bipolar spectrum disorders. Results should be interpreted in light of limitations, which include exclusion of severely ill subjects, 54% completion rate, and small sample size. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01396486. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/26646031/A_randomized_clinical_trial_of_high_eicosapentaenoic_acid_omega_3_fatty_acids_and_inositol_as_monotherapy_and_in_combination_in_the_treatment_of_pediatric_bipolar_spectrum_disorders:_a_pilot_study_ L2 - http://www.psychiatrist.com/jcp/article/pages/2015/v76n11/v76n1124.aspx DB - PRIME DP - Unbound Medicine ER -