Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder

Inclusion Criteria:

• Males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar disorder.
• Subject and parent/ legal guardian 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 parent/ legal representative must be considered reliable.
• Each subject and his/her parent or authorized legal representative must understand the nature of the study. The subject's parent or authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
• One parent/ legal guardian must be able to accompany the subject to the clinic at each visit.

Exclusion Criteria:

• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
• Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
• Mental retardation