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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT00067262•Abbott

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - 17 years

Sex

ALL

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
+2 more criteria

Locations (16)

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

Key Dates

Start Date

March 1, 2003

Last Updated

August 4, 2006

Enrollment

150

Estimated participants

Conditions

Bipolar Disorder

Interventions

Divalproex Sodium Extended-Release Tablets

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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