An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
NCT ID: NCT00067262
Last Updated: 2006-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Divalproex Sodium Extended-Release Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Global Medical Information
Role: STUDY_DIRECTOR
Abbott
Locations
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Stanford University
Stanford, California, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Altamonte Springs, Florida, United States
Professional Clinical Research, Inc.
Miami, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Mountain West Clinical Trials
Boise, Idaho, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Cientifica Inc at Praire View, Inc.
Newton, Kansas, United States
Lexington, Kentucky, United States
LSU - Health Science Center
New Orleans, Louisiana, United States
Brentwood Research Institute
Shreveport, Louisiana, United States
New Oakland Child/Adoles and Family Center
Clinton Township, Michigan, United States
Mercy Health Research
Chesterfield, Missouri, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas Medical Branch
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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M01-342
Identifier Type: -
Identifier Source: org_study_id