Expired Study
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North Chicago, Illinois 60064


Purpose:

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.


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 </= 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.


NCT ID:

NCT00195767


Primary Contact:

Study Director
Global Medical Information 800-633-9110
Abbott


Backup Contact:

N/A


Location Contact:

North Chicago, Illinois 60064
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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