Please select the eligibility criteria that correspond to the clinical trial below.
Title: Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder
Brief Summary: The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus lithium or divalproex used with lamotrigine is more effective when symptoms of depression develop.


Options:
A: Inclusion Criteria:

1. Bipolar I or II
2. Currently either in remission or subsyndromally ill (Hamilton Depression Scale-17\<14; Clinician Administered Rating Scale for Mania\<12).
3. Age eighteen to sixty.
4. Significant symptoms and/or episodes on at least two occasions in the past three years.
5. Grade six education, able to understand English, and Folstein Minimental Score Exam \> 26 to ensure cognitive ability to participate.
6. On mood-stabilizing medication.

Exclusion Criteria:

1. Substance dependence meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria within the last three months.
2. Acutely highly suicidal or homicidal.
3. Serious other medical condition that would render pharmacotherapy or psychotherapy very difficult such as cancer, severe diabetes, etc.
4. Severe antisocial or borderline personality disorder (personality disorder per se is not exclusionary). Subjects may have other axis I disorders, but bipolar disorder must be the principal disorder requiring treatment.
B: Inclusion

* Patients must provide written and informed consent.
* Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

* Patients must not be suicidal.
* Patients must not have a history of non-response to antidepressant treatment.
* Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry.
* Patients must not have had epilepsy or hypothyroidism.
C: Inclusion Criteria:

* Patients must provide written and informed consent
* Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
* Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior

Exclusion Criteria:

* Patients must not be suicidal
* Patients must not have a history or non-response to antidepressant treatment
* Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
* Patients must not have had epilepsy or hypothyroidism
D: Inclusion Criteria:

* DSM-IV TR (Diagnostic and Statistical Manual Edition IV Text Revision) diagnosis BD I or II as assessed by MINI PLUS (Mini International Neuropsychiatric Interview PLUS)
* Male or female ≥ 18 years old
* Currently symptomatic with a CGI-BP-S ≥3 for mania/hypomania \&/or depression for ≥ 2 weeks
* One of the following indicators of recent active illness: a depressive or manic or hypomanic or mixed episode in the past 12 months
* If female of child bearing age must use effective birth control.

Exclusion Criteria:

* Unwilling or unable to comply with study requirements
* Renal impairment (serum creatinine \> 1.5 mg/dL)
* If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1
* Patients who have had intolerable side effects to QTP, Li, Div, or LTG
* Patients whose clinical status requires inpatient care
* Drug/alcohol dependence within the past 30 days
* Pregnancy as determined by serum pregnancy test or breastfeeding
* History of poor response to Li at a serum Li of ≥ 0.5 mEq/L (milliequivalents per Liter) or Div at a serum level of ≥ 45 mg/dL for at least 2 weeks.

Answer: D