An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
Bipolar Disorder
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder Type 1 (manic or mixed type)
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
Sites / Locations
- Stanford University
- Childrens National Medical Center
- Professional Clinical Research, Inc.
- Segal Institute for Clinical Research
- Mountain West Clinical Trials
- Capstone Clinical Research
- Cientifica Inc at Praire View, Inc.
- LSU - Health Science Center
- Brentwood Research Institute
- New Oakland Child/Adoles and Family Center
- Mercy Health Research
- Cutting Edge Research Group
- University of Texas Medical Branch
- University of Texas Medical Branch