Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bipolar I Disorder, Manic or Mixed

Intervention / Treatment
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* Drug: divalproex sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: divalproex sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcome measures |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Y-MRS |  |  | 
| CGI-S |  |  | 
| C-GAS |  |  | 
| CDRS-R |  |  | 
| CGSQ |  |  | 
| responders |  |  | 
| remitters |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar I Disorder, Depakote ER, divalproex sodium