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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00067262

Purpose

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	Intervention	Phase
Bipolar Disorder	Drug: Divalproex Sodium Extended-Release Tablets	Phase III

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Vital signs
Adverse events

Estimated Enrollment:	150
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067262

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

No publications provided by Abbott

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	M01-342
Study First Received:	August 13, 2003
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00067262 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Bipolar Disorder Type 1 (manic or mixed type)

Study placed in the following topic categories:

Neurotransmitter Agents
Affective Disorders, Psychotic
Tranquilizing Agents
Mental Disorders
Bipolar Disorder
Psychotropic Drugs

Mood Disorders
Central Nervous System Depressants
Psychotic Disorders
Antimanic Agents
Valproic Acid
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents

Valproic Acid
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009