Inositol and Omega-3 Fatty Acids in Pediatric Mania
Condition: Pediatric Bipolar Spectrum Disorders
MeSH terms: Mania
Intervention: Omega-3; Inositol
Intervention description: Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.; Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
Intervention MeSH terms: Inositol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Omega-3 Fatty Acids; Fish Oil; Inositol; Natural supplements; Bipolar Spectrum Disorders; Mania; Depression; Children

Summary:

      The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus
      inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3
      fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the
      side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial
      with children ages 5-12 years old with bipolar spectrum disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects, 5-12 years of age.

          2. Subjects must have a DSM-IV diagnosis of a bipolar spectrum disorder (type I, II, or
             Not Otherwise Specified (NOS)), and currently displaying mixed, manic, or hypomanic
             symptoms (without psychotic features) according to the DSM-IV based on clinical
             assessment and confirmed with structured diagnostic interview (Schedule of Affective
             Disorders and Schizophrenia for School-Age Children - Epidemiological Version
             (K-SADS-E)) (Orvaschel, 1994).

          3. Subjects and their legal representative must have a level of understanding sufficient
             to communicate intelligently with the investigator and study coordinator, and to
             cooperate with all tests and examinations required by the protocol.

          4. Subjects and their legal representative must be considered reliable.

          5. Each subject and his/her authorized legal representative must understand the nature of
             the study. The subject's authorized legal representative must sign an informed consent
             document and the subject must sign an informed assent document.

          6. Subjects must have an initial score on the YMRS total score of at least 20.

          7. Subject must be able to swallow pills.

          8. Subjects with ADHD and ODD will be allowed to participate in the study provided that
             the impairment associated with these disorders is of mild or moderate severity (not
             severe) and milder in severity relative to the impairment of the bipolar disorder,
             according to clinician evaluation. Subjects with comorbid anxiety disorders will be
             allowed to participate provided that the impairment associated with the anxiety is of
             minimal severity, according to clinician evaluation. Subjects with comorbid CD will be
             excluded.

        Exclusion Criteria:

          1. Investigator and his/her immediate family; defined as the investigator's spouse,
             parent, child, grandparent, or grandchild.

          2. Serious or unstable illness including hepatic, renal, gastroenterological,
             respiratory, cardiovascular (including ischemic heart disease), endocrinologic,
             neurologic, immunologic, or hematologic disease.

          3. History of bleeding diathesis, including those with von Willebrand disease.

          4. Uncorrected hypothyroidism or hyperthyroidism.

          5. History of sensitivity to omega-3 fatty acids or inositol. A non-responder or history
             of intolerance to omega-3 fatty acid or inositol, after 2 months of treatment at
             adequate doses as determined by the clinician.

          6. Severe allergies or multiple adverse drug reactions.

          7. Failed 2 or more previous trials with anti-manic treatments including lithium,
             anticonvulsants and atypical antipsychotic medication.

          8. Current or past history of seizures.

          9. DSM-IV substance use, abuse or dependence (unlikely in ages 5-12).

         10. Judged clinically to be at serious suicidal risk.

         11. Current diagnosis of schizophrenia.

         12. Current diagnosis of conduct disorder

         13. Pregnancy (unlikely in ages 5-12).

         14. YMRS Item #8 (Content) score of 8 ("delusions; hallucinations").

         15. YMRS total score above 40.

         16. Girls who have begun menstruating.

         17. C-SSRS score ≥ 4.

         18. IQ < 70.