Inclusion Criteria:
Inclusion Criteria:
- Subject and subject's legal representative have voluntarily signed and dated an
IRB-approved informed assent form and an IRB-approved informed consent form,
respectively, before any study-specific procedures or tests are performed.
- The subject was randomized into Study M01-342 and either completed the study or
prematurely discontinued due to ineffectiveness.
- The subject is male or a non-pregnant, non-lactating female.
- Subject is judged to be in general good health based upon the results of a physical
examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory profile (as
described in Section 5.3.1)
Exclusion Criteria
- Subject is female, of childbearing potential, and not using an effective method of
birth control (e.g., total sexual abstinence or contraceptives).
- Subject experienced a serious adverse event in Study M01-342, which the investigator
considered "possibly" or "probably related" to study drug.
- Subject is violent, homicidal, or suicidal such that, in the opinion of the
investigator, the subject is at significant imminent risk of hurting self or others.
- Subject has any of the following abnormal laboratory results at the last assessment
prior to Day 1: Platelet count /= 2 times Upper Limit of
Normal (ULN)
- The subject is taking a protocol allowed medication for ADHD that has not been stable
for at least 3 months prior to Day 1, is expected to require a dosage adjustment
during the study, or that, in the investigators opinion, may be exacerbating mood
symptoms.
- Subject requires treatment with or has taken a protocol-prohibited medication (see
Appendix D) within 5 elimination half lives of Day 1.
- Subject has received an investigational drug, other than Depakote ER in Study M01-342,
within 30 days prior to Day 1 of this study.
- In the investigator's opinion, long-term treatment with Depakote ER for the subject's
mania associated with bipolar disorder is contraindicated.
- For any reason, subject is considered by the investigator to be an unsuitable
candidate for this study.
