Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abbott
Treatments:
Valproic Acid
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 /= 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.