An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
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
1 other identifier
interventional
150
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 13, 2003
CompletedFirst Posted
Study publicly available on registry
August 15, 2003
CompletedAugust 4, 2006
August 1, 2006
August 13, 2003
August 2, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to the final evaluation in Y-MRS score.
Secondary Outcomes (2)
Vital signs
Adverse events
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (16)
Stanford University
Stanford, California, 94304, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Altamonte Springs, Florida, 32701, United States
Professional Clinical Research, Inc.
Miami, Florida, 33161, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Mountain West Clinical Trials
Boise, Idaho, 83704, United States
Capstone Clinical Research
Libertyville, Illinois, 60031, United States
Cientifica Inc at Praire View, Inc.
Newton, Kansas, 67114, United States
Unknown Facility
Lexington, Kentucky, 40509, United States
LSU - Health Science Center
New Orleans, Louisiana, 70112, United States
Brentwood Research Institute
Shreveport, Louisiana, 71101, United States
New Oakland Child/Adoles and Family Center
Clinton Township, Michigan, United States
Mercy Health Research
Chesterfield, Missouri, 63017, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
University of Texas Medical Branch
Galveston, Texas, 77705, United States
University of Texas Medical Branch
Houston, Texas, 77058, United States
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: 19325497DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Information
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 13, 2003
First Posted
August 15, 2003
Study Start
March 1, 2003
Last Updated
August 4, 2006
Record last verified: 2006-08