Lead Sponsor

Nationwide Children's Hospital

Collaborators

Age

3 - 7 years

Sex

ALL

Healthy Volunteers

No

•Subjects were male or female outpatient subjects,
•3.0 - 7 years 11 months of age
•Bipolar I or II Disorder, mixed, manic or hypomanic episode, psychotic or non-psychotic, according to DSM IV criteria (American Psychiatric Association 1994)
•with a score \> 20 on the Young Mania Rating Scale (YMRS.

•clinically significant or unstable hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions;
•neurologic disorders including epilepsy, stroke, or severe head trauma those clinically significant laboratory abnormalities, on any of the following tests:
•* CBC with differential,
•* electrolytes,
•* BUN,
•* creatinine,
•* hepatic transaminases,
•* urinalysis,
•* thyroid indices (T3, Total T4, Free T4, TSH) and
•* EKG
•mania due to a general medical condition or substance-induced mania
•mental retardation (IQ \<70),
•evidence of Fetal Alcohol Syndrome or an Alcohol-Related Neurodevelopmental Disorder,
•Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.

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