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

NCT00195767 | Completed Phase 3

• 1 other identifier: M02-555
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar I Disorder, Manic or Mixed

Keywords

Bipolar I Disorder; Depakote ER; divalproex sodium

Outcome Measures

Primary Outcomes (1)

• Safety outcome measures

Secondary Outcomes (7)

• Y-MRS

• CGI-S

• C-GAS

• CDRS-R

• CGSQ

Interventions

divalproex sodium DRUG

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Global Medical Information-Abbott

North Chicago, Illinois, 60064, United States

Location

Related Publications (1)

• Wagner KD, Redden L, Kowatch RA, Wilens TE, Segal S, Chang K, Wozniak P, Vigna NV, Abi-Saab W, Saltarelli M. A double-blind, randomized, placebo-controlled trial of divalproex extended-release in the treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):519-532. doi: 10.1097/CHI.0b013e31819c55ec.

  PMID: 19325497 DERIVED

MeSH Terms

Conditions

Mania

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Global Medical Information 800-633-9110

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2004
• Last Updated: March 19, 2007

Record last verified: 2007-03

Locations

US (1)