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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder	Drug: Divalproex Sodium Extended-Release Tablets	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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 Start Date :	March 2003

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Vital signs
2. Adverse events

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
Stanford University
Stanford, California, United States, 94304
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Altamonte Springs, Florida, United States, 32701
Professional Clinical Research, Inc.
Miami, Florida, United States, 33161
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Idaho
Mountain West Clinical Trials
Boise, Idaho, United States, 83704
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States, 60031
United States, Kansas
Cientifica Inc at Praire View, Inc.
Newton, Kansas, United States, 67114
United States, Kentucky
Lexington, Kentucky, United States, 40509
United States, Louisiana
LSU - Health Science Center
New Orleans, Louisiana, United States, 70112
Brentwood Research Institute
Shreveport, Louisiana, United States, 71101
United States, Michigan
New Oakland Child/Adoles and Family Center
Clinton Township, Michigan, United States
United States, Missouri
Mercy Health Research
Chesterfield, Missouri, United States, 63017
United States, Oklahoma
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77705
University of Texas Medical Branch
Houston, Texas, United States, 77058

Sponsors and Collaborators

Abbott

Investigators

Study Director:	Global Medical Information	Abbott

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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):519-32. doi: 10.1097/CHI.0b013e31819c55ec.

ClinicalTrials.gov Identifier:	NCT00067262 History of Changes
Other Study ID Numbers:	M01-342
First Posted:	August 15, 2003
Last Update Posted:	August 4, 2006
Last Verified:	August 2006

Keywords provided by Abbott:

Bipolar Disorder Type 1 (manic or mixed type)

Additional relevant MeSH terms:

Disease; Bipolar Disorder; Pathologic Processes; Bipolar and Related Disorders; Mental Disorders; Valproic Acid; Anticonvulsants; Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action; GABA Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Antimanic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs