Gao NARASD Lithium Study

Inclusion Criteria:

For inclusion in this study, subjects must meet all of the following criteria:

1. Able to provide informed consent before beginning any study-specific procedures;

2. Male or female, 18-70 years old;

3. Meets current DSM-5 criteria for bipolar I or II disorder as assessed by the The
M.I.N.I. International Neuropsychiatric Interview (MINI);

4. Any symptomatic phase of bipolar I or II disorder including, depressive, manic, mixed
or hypomanic

5. Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≥3;

6. Willing to take lithium;

7. If a sexually active female of childbearing potential, be using a reliable method of
contraception;

8. Women with reproductive potential must have a negative urine pregnancy test;

9. Willing to have blood drawn:

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. Unwilling to comply with study requirements;

2. Renal impairment (serum creatinine >1.5 mg/dL);

3. Thyroid stimulating hormone (TSH) over >20% above the upper normal limit (participants
maintained on thyroid medication must be euthyroid for at least 3 months before Visit
1;

4. Other contraindication to lithium,

5. Patients who have had severe adverse reaction to Lithium;

6. Patients who require inpatient care;

7. Drug/alcohol dependence requiring immediate acute detoxification;

8. Pregnancy as determined by serum pregnancy test or breastfeeding;

9. History of nonresponse to lithium at doses ≥ 900 mg/d for ≥ 8 weeks;

10. Unwilling to have blood drawn

11. Patients with chronic medical conditions such as diabetes, coronary artery disease,
immune diseases, infectious diseases and neurological disorders;

12. Active suicidal ideation with a plan or intent, a suicide attempt within past 6 months
or more than 2 suicide attempts within the past 2 years.

13. Currently on lithium