Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.

Exclusion Criteria

• •1. Participant who is clinically stable on current medication regimen for bipolar disorder
• •2. A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder (ASQ score \> 15), Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder
• •3. Current DSM-IV diagnosis of Substance Dependence
• •4. Positive drug screen at screening and on retest 1-3 weeks later
• •5. Participants with symptoms of mania that may be attributable to a general medical condition, or secondary to use of medications (e.g., corticosteroids)
• •6. Evidence of any serious, unstable neurological illness for which treatment under the auspices of this study would be contraindicated
• •7. Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol
• •8. Current general medical condition including neurological disease, diabetes mellitus, thyroid dysfunction, or renal dysfunction that might be affected adversely by lithium, could influence the efficacy or safety of lithium, or would complicate interpretation of study results
• •9. Evidence of current serious homicidal/suicidal ideation such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study
• •10. Evidence of current active hallucinations and delusions such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study
• •11. Concomitant prescription of over-the-counter medication or nutritional supplements (e.g., ibuprofen, naproxen, St John's wort) that would interact with lithium or affect the participant's physical or mental status
• •12. Concomitant psychotherapy treatments provided outside the study initiated within 4 weeks prior to screening
• •13. Previous adequate trial with Li+ (at least 4 weeks with Li+ serum levels between 0.8-1.2 mEq/L)
• •14. History of allergy to lithium or lithium intolerance
• •15. Psychiatric hospitalization within 1 month of screening for psychosis or serious homicidal/serious suicidal ideation
• •16. Clinician's judgment that participant is not likely to be able to complete the study as an outpatient due to psychiatric reasons
• •17. Females who are currently pregnant or lactating
• •18. Sexually active females who, in the investigators' opinion, are not using an adequate form of birth control.
• •19. Participants who are unable to swallow the study medication
• •20. Participants for whom a baseline YMRS score of \< 20 is anticipated
• •21. Participants with an IQ less than 70 (determined using the Wechsler Abbreviated Scales of Intelligence {WASI} Vocabulary and Matrix Reasoning Subscales)