Gao NARASD Lithium Study
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium
Intervention description: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L
Intervention MeSH terms: Lithium Carbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study is a 4-month open-label study of lithium in the acute treatment of patients with
      bipolar I or II disorder. Eligible patients will receive lithium 300 mg twice daily and
      titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L. Blood samples
      are collected at baseline and at the end of study. Analyses of 45 molecule expressions in
      mononuclear blood cells at baseline and endpoint will be carried out after the completion of
      study. Fifty patients meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
      criteria for bipolar I or II will be enrolled.
    

Eligibility criteria:

        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