Status:
COMPLETED
Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
Lead Sponsor:
Abbott
Conditions:
Bipolar I Disorder, Manic or Mixed
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00195767
Start Date
July 1 2004
Last Update
March 19 2007
Active Locations (1)
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1
Global Medical Information-Abbott
North Chicago, Illinois, United States, 60064