Official Title: “An Open-Label Long-Term Study to Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents”

To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: divalproex sodium

Primary Measures

• Safety outcome measures

Secondary Measures

• Y-MRS
• CGI-S
• C-GAS
• CDRS-R
• CGSQ
• responders
• remitters

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 </= 100,000/µL; ALT or AST >/= 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information 800-633-9110 Study Director Abbott  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195767

Study ID Number: M02-555

ClinicalTrials.gov Identifier: NCT00195767

Health Authority: United States: Food and Drug Administration