Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old

Inclusion Criteria:

1. Male and female subjects 6-17 years of age

2. Subjects must weigh at least 20 kg

3. Subjects with the diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder and
currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic
features), by DSM-IV (Diagnostic and Statistical Manual IV), as manifested in clinical
evaluation and/or the Mania module of the structured interview, completed by the study
clinician. Bipolar Spectrum Disorder (or sub-threshold bipolar disorder) is
operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for
bipolar disorder but displays fewer elements in Criteria B (only require 2 items for
elation category and 3 for irritability)

4. Subjects must score ≥ 20 on the YMRS (Young Mania Rating Scale)

5. 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.

6. Subjects and their legal representative must be considered reliable reporters.

7. 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 (if ≥ 7 years old).

8. Subject must be able to participate in mandatory blood draws.

9. Subject must be able to swallow pills.

10. Subjects with co-morbid PDD (Pervasive Developmental Disorder) and depressive
disorders will be allowed to participate in the study provided they do not meet any of
the exclusionary criteria.

11. For concomitant therapy used to treat ADHD (Attention Deficit Hyperactivity Disorder),
subjects must have been on a stable dose of the medication for 1 month prior to study
enrollment, and the dose of the ADHD therapy cannot change throughout the duration of
the study.

Exclusion Criteria:

1. Investigator and his/her immediate family; defined as the investigator's spouse,
parent, child, grandparent, or grandchild.

2. Serious, unstable illness including hepatic, renal, gastroenterological, respiratory,
cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
immunologic, or hematologic disease.

3. Uncorrected hypothyroidism or hyperthyroidism.

4. Non-febrile seizures without a clear and resolved etiology.

5. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.

6. Judged clinically to be at serious suicidal risk or have a C-SSRS (Columbia Suicide
Severity Rating Scale) score ≥ 4.

7. Any other concomitant medication with primary central nervous system activity other
than specified in the Concomitant Medication portion of the Protocol.

8. Current diagnosis of schizophrenia.

9. Mental retardation (IQ < 75)

10. Pregnant or nursing females

11. Known hypersensitivity to Latuda®

12. A non-responder or history of intolerance to Latuda®, after treatment at adequate
doses as determined by the clinician.

13. Severe allergies or multiple adverse drug reactions.

14. Subjects with a hematological disorder.

15. Subjects with diabetes.