Inositol and Omega-3 Fatty Acids in Pediatric Mania

Inclusion Criteria:

• Male or female subjects, 6-12 years of age.
• Subjects must have a DSM-IV diagnosis of bipolar spectrum disorder (types I, II, and not otherwise specified) and currently be displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and structured diagnostic interview (Kiddie Schedule of Affective Disorders and Schizophrenia Epidemiological Version, Orvaschel, 1994).
• 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.
• Subjects and their legal representative must be considered reliable.
• 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.
• Subjects must have an initial total score on the YMRS of at least 20.
• Subject must be able to participate in mandatory blood draws.
• Subject must be able to swallow pills.
• Subjects with ADHD, ODD, conduct disorder, and anxiety will be allowed to participate in the study provided that the impairment associated with these disorders is of a lesser degree of severity relative to the impairment of the bipolar disorder, according to clinician evaluation.

Exclusion Criteria:

• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
• Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• History of bleeding diathesis, including those with von Willebrand disease.
• Uncorrected hypothyroidism or hyperthyroidism.
• History of sensitivity to omega-3 fatty acids or inositol. A non-responder or history of intolerance to omega-3 or inositol, after 2 months of treatment at adequate doses as determined by the clinician.
• Severe allergies or multiple adverse drug reactions.
• Failed 2 or more previous trials with anti-manic treatments including lithium, anticonvulsants, and atypical antipsychotic medication.
• Current or past history or seizures.
• DSM-IV substance use, abuse, or dependence (unlikely in ages 6-12).
• Judged clinically to be at serious suicidal risk.
• Any other concomitant medication with primarily central nervous system activity other than no greater than 2mg lorazepam taken no more than 3 days during the study.
• Current diagnosis of schizophrenia.
• Pregnancy (unlikely in ages 6-12).
• Girls who have begun menstruating.
• YMRS Item #8 (Content) score of 8 ("delusions; hallucinations").
• YRMS total score above 40.
• Girls who have begun menstruating.
• C-SSRS score <4.
• IQ <70.