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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

Primary Purpose

Bipolar I Disorder, Manic or Mixed

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
divalproex sodium
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Disorder, Manic or Mixed focused on measuring Bipolar I Disorder, Depakote ER, divalproex sodium

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Global Medical Information-Abbott

Outcomes

Primary Outcome Measures

Safety outcome measures

Secondary Outcome Measures

Y-MRS
CGI-S
C-GAS
CDRS-R
CGSQ
responders
remitters

Full Information

First Posted
September 14, 2005
Last Updated
March 17, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00195767
Brief Title
Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
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 Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder, Manic or Mixed
Keywords
Bipolar I Disorder, Depakote ER, divalproex sodium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
divalproex sodium
Primary Outcome Measure Information:
Title
Safety outcome measures
Secondary Outcome Measure Information:
Title
Y-MRS
Title
CGI-S
Title
C-GAS
Title
CDRS-R
Title
CGSQ
Title
responders
Title
remitters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information 800-633-9110
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information-Abbott
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19325497
Citation
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.
Results Reference
derived

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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

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