Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Brief Summary: The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.


Options:
A: 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
B: Inclusion Criteria:

* Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic episodes

Exclusion Criteria:

* Rapid cycling bipolar disorder
* History of substance abuse or dependence within last 3 months
* Diagnosis of schizophrenia or other chronic psychotic conditions
* Acute or unstable medical illness
* Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam
* Dementia
* Inability to communicate in English
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:

* You must be 18 to 65 years old.
* You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
* You must be able to visit the doctor's office as scheduled for 15 weeks.
* All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.

Exclusion Criteria:

* You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.
* You are pregnant or breastfeeding
* You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.

Answer: A