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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067262
• Other study ID #: M01-342
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2003
• Last updated: August 2, 2006
• Start date: March 2003

Study information

• Verified date: August 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Divalproex Sodium Extended-Release Tablets

Locations

Country	Name	City	State
United States	Mountain West Clinical Trials	Boise	Idaho
United States	Mercy Health Research	Chesterfield	Missouri
United States	New Oakland Child/Adoles and Family Center	Clinton Township	Michigan
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Texas Medical Branch	Houston	Texas
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Professional Clinical Research, Inc.	Miami	Florida
United States	LSU - Health Science Center	New Orleans	Louisiana
United States	Cientifica Inc at Praire View, Inc.	Newton	Kansas
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Brentwood Research Institute	Shreveport	Louisiana
United States	Stanford University	Stanford	California
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to the final evaluation in Y-MRS score.
Secondary	Vital signs
Secondary	Adverse events