Clinical trial NCT00067262: An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder Type 1 (manic or mixed type)
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline to the final evaluation in Y-MRS score.
Secondary outcomes:
measure: Vital signs
measure: Adverse events
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Altamonte Springs
country: United States
state: Florida
city: Miami
country: United States
facility: Professional Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Boise
country: United States
facility: Mountain West Clinical Trials
state: Idaho
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Newton
country: United States
facility: Cientifica Inc at Praire View, Inc.
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
facility: LSU - Health Science Center
state: Louisiana
city: Shreveport
country: United States
facility: Brentwood Research Institute
state: Louisiana
city: Clinton Township
country: United States
facility: New Oakland Child/Adoles and Family Center
state: Michigan
city: Chesterfield
country: United States
facility: Mercy Health Research
state: Missouri
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References:
citation: 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.