Inositol and Omega-3 Fatty Acids in Pediatric Mania
Condition: Pediatric Bipolar Spectrum Disorders
MeSH terms: Mania
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The investigators propose to conduct a randomized, double blind, controlled trial that will
      evaluate effectiveness and tolerability of omega-3 fatty acids and inositol used alone and in
      combination. The investigators plan to decrease the variability in the population under study
      by limiting the age range to 5-12 years and excluding cases with significant, untreated,
      comorbidity. The cognitive effects/side effects with a neuropsychological battery pre and
      post treatment will be measured. Subjects with a history of failing treatment with two or
      more conventional treatments will be excluded.

      This will be a 12-week, double-blind, randomized clinical trial study to compare efficacy and
      tolerability of the natural treatments omega-3 fatty acids and inositol used in combination
      in the treatment of bipolar spectrum disorders in children and adolescents (ages 5-12).
      Subjects will be randomized in double blind fashion to one of three arms: omega-3 fatty
      acids, inositol or the combined treatment. Further, the proposed study will include measures
      of cognition prior to starting study medication and at endpoint. The investigators will
      minimize the variability of the population under study by limiting the age range to 5-12
      years, minimizing untreated or clinically significant comorbidity and excluding subjects who
      have already failed treatment with 2 or more anti-manic agents. Subjects will include youth
      ages 5-12 years with a bipolar spectrum disorder (type I, II, or NOS), mixed, manic, or
      hypomanic state, according to the Diagnostic and Statistical Manual of Mental Disorders,
      Fourth Edition (American Psychiatric Association, 2000) (DSM-IV), randomized to 3 treatment
      arms: 1) treatment with omega-3 fatty acids (N=20); 2) treatment with inositol (N=20); 3)
      treatment with the combination of inositol and omega-3 fatty acids (N=20).
    

Intervention name(s): Omega-3; Inositol
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): ProOmega Junior
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Omega-3 Fatty Acids; Fish Oil; Inositol; Natural supplements; Bipolar Spectrum Disorders; Mania; Depression; Children