Please select the eligibility criteria that correspond to the clinical trial below.
Title: "A Randomized, Double-Blind, Placebo-Controlled Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania"
Brief Summary: The purpose of this research study is to evaluate the safety, tolerability, and efficacy of divalproex extended release compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex extended release is approved by the United States Food and Drug Administration (FDA) for the treatment of epilepsy and for prevention of migraine headaches.


Options:
A: 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
B: Inclusion Criteria:

* Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
* The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.

Exclusion Criteria:

* Schizophrenia or schizoaffective disorder
* Mental retardation
* Unstable clinical diseases
C: Inclusion Criteria:

1. Subjects must be 18 years of age or older.
2. Subjects must have bipolar I, II, or NOS disorder as defined by DSM-IV-TR. (Bipolar NOS will include hypomania defined as in DSM-IV-TR, as well as "brief" hypomania-hypomania occurring for a duration of \> 1 day but \< 4 days - and antidepressant associated hypomania and mania).
3. Subjects must have moderate-to-severe hypomania or mild mania within the past 2 weeks, defined as having a YMRS \>10 and \< 21 at the baseline assessment.
4. Subjects' overall bipolar symptoms must be clinically significant but not greater than severe (defined as a CGI-BP \>2 and \< 5).
5. Subjects must be outpatients.
6. Subjects must be on no psychotropics for 1 week (2 weeks for fluoxetine and 4 weeks for depot antipsychotics) except for prn lorazepam (.5-2mg/day) or zaleplon (5-10mg qhs).
7. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
8. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, intrauterine device) for at least one month prior to study entry and throughout the study.

Exclusion Criteria:

1. Subjects who do not have bipolar disorder by above DSM-IV-TR criteria.
2. Subjects whose bipolar symptoms are more than severely ill (CGI-BP \> 5, YMRS \> 21, or IDS \> 39).
3. Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
4. Subjects who require hospitalization.
5. Subjects with clinically significant suicidal ideation, homicidal ideation, or psychotic features.
6. Subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders or a lifetime psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
7. Subjects with DSM-IV Axis I substance dependence within the past 3 months (except for nicotine dependence).
8. Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement \> 3 months.
9. Subjects who are allergic to or who have demonstrated hypersensitivity to any valproate or divalproex preparation.
10. Women who are pregnant or nursing.
11. Subjects who have received an experimental drug or used an experimental device within 30 days.
D: 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

Answer: C