Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-Label Long-Term Study to Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
Brief Summary: To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.


Options:
A: Inclusion Criteria:

* Children with Bipolar Disorder
* Must be able to swallow tablets

Exclusion Criteria:

* Children with general medical condition such as head injury, epilepsy, endocrine disorders
* Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
* If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.

We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.
B: 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
C: INCLUSION CRITERIA

* Current primary diagnosis of bipolar I disorder, mania or mixed type
* Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score \>= 18
* Hospitalized no more than 7 days at time of Screening or in process of being admitted
* History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement

EXCLUSION CRITERIA

* History of schizophrenia or schizoaffective disorder
* Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
* Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
* Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
* Had first manic episode after age 60
* Has ever taken clozapine
* Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
* History of active alcohol or substance dependence within past 3 months.
* History of failed treatment on adequate valproate therapy for bipolar disorder
* Has taken Depakote (DR or ER) regularly over the last 30 days
* Has serious violent, homicidal, or suicidal ideation
D: Inclusion Criteria:

* Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed.
* The subject was randomized into Study M01-342 and either completed the study or prematurely discontinued due to ineffectiveness.
* The subject is male or a non-pregnant, non-lactating female.
* Subject is judged to be in general good health based upon the results of a physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory profile (as described in Section 5.3.1)

Exclusion Criteria

* Subject is female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
* Subject experienced a serious adverse event in Study M01-342, which the investigator considered "possibly" or "probably related" to study drug.
* Subject is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others.
* Subject has any of the following abnormal laboratory results at the last assessment prior to Day 1: Platelet count \</= 100,000/µL; ALT or AST \>/= 2 times Upper Limit of Normal (ULN)
* The subject is taking a protocol allowed medication for ADHD that has not been stable for at least 3 months prior to Day 1, is expected to require a dosage adjustment during the study, or that, in the investigators opinion, may be exacerbating mood symptoms.
* Subject requires treatment with or has taken a protocol-prohibited medication (see Appendix D) within 5 elimination half lives of Day 1.
* Subject has received an investigational drug, other than Depakote ER in Study M01-342, within 30 days prior to Day 1 of this study.
* In the investigator's opinion, long-term treatment with Depakote ER for the subject's mania associated with bipolar disorder is contraindicated.
* For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Answer: D