Bipolar I Disorder, Manic or Mixed
Conditions
Keywords
Bipolar I Disorder, Depakote ER, divalproex sodium
Brief summary
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.
Interventions
DRUGdivalproex sodium
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome measures | — |
Secondary
| Measure | Time frame |
|---|---|
| CDRS-R | — |
| CGSQ | — |
| responders | — |
| C-GAS | — |
| Y-MRS | — |
| CGI-S | — |
| remitters | — |
Countries
United States
Outcome results
None listed