Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
10–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
