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

Information source: Abbott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar I Disorder, Manic or Mixed

Intervention: divalproex sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Medical Information 800-633-9110, Study Director, Affiliation: Abbott

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety outcome measures

Secondary outcome:

Y-MRS

CGI-S

C-GAS

CDRS-R

CGSQ

responders

remitters

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Global Medical Information-Abbott, North Chicago, Illinois 60064, United States
Additional Information

Starting date: July 2004
Last updated: March 17, 2007

Page last updated: August 20, 2015

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