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An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Divalproex Sodium Extended-Release Tablets
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder Type 1 (manic or mixed type)

Eligibility Criteria

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

INCLUSION CRITERIA Current primary diagnosis of bipolar I disorder, mania or mixed type Outpatient between 10 and 17 years of age Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1 EXCLUSION CRITERIA Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism) Expected to require hospitalization for the current manic episode Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms Unable to swallow tablets Has received depot psychoactive medication within one inter-injection interval of Day 1 Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines History of alcohol or substance dependence within past 3 mos. or substance abuse within past month History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months Has taken Depakote (DR or ER) regularly for the current manic episode Has serious violent, homicidal, or suicidal ideation

Sites / Locations

  • Stanford University
  • Childrens National Medical Center
  • Professional Clinical Research, Inc.
  • Segal Institute for Clinical Research
  • Mountain West Clinical Trials
  • Capstone Clinical Research
  • Cientifica Inc at Praire View, Inc.
  • LSU - Health Science Center
  • Brentwood Research Institute
  • New Oakland Child/Adoles and Family Center
  • Mercy Health Research
  • Cutting Edge Research Group
  • University of Texas Medical Branch
  • University of Texas Medical Branch

Outcomes

Primary Outcome Measures

Change from baseline to the final evaluation in Y-MRS score.

Secondary Outcome Measures

Vital signs
Adverse events

Full Information

First Posted
August 13, 2003
Last Updated
August 2, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00067262
Brief Title
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
Official Title
A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
March 2003 (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
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder Type 1 (manic or mixed type)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium Extended-Release Tablets
Primary Outcome Measure Information:
Title
Change from baseline to the final evaluation in Y-MRS score.
Secondary Outcome Measure Information:
Title
Vital signs
Title
Adverse events

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 Current primary diagnosis of bipolar I disorder, mania or mixed type Outpatient between 10 and 17 years of age Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1 EXCLUSION CRITERIA Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism) Expected to require hospitalization for the current manic episode Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms Unable to swallow tablets Has received depot psychoactive medication within one inter-injection interval of Day 1 Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines History of alcohol or substance dependence within past 3 mos. or substance abuse within past month History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months Has taken Depakote (DR or ER) regularly for the current manic episode Has serious violent, homicidal, or suicidal ideation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Childrens National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Professional Clinical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Mountain West Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Cientifica Inc at Praire View, Inc.
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
LSU - Health Science Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Brentwood Research Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
New Oakland Child/Adoles and Family Center
City
Clinton Township
State/Province
Michigan
Country
United States
Facility Name
Mercy Health Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77705
Country
United States
Facility Name
University of Texas Medical Branch
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
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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An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

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