Gao NARASD Lithium Study

Study Overview
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Brief Summary
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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.

Official Title
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Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Lithium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For inclusion in this study, subjects must meet all of the following criteria: Able to provide informed consent before beginning any study-specific procedures; Male or female, 18-70 years old; Meets current DSM-5 criteria for bipolar I or II disorder as assessed by the The M.I.N.I. International Neuropsychiatric Interview (MINI); Any symptomatic phase of bipolar I or II disorder including, depressive, manic, mixed or hypomanic Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≥3; Willing to take lithium; If a sexually active female of childbearing potential, be using a reliable method of contraception; Women with reproductive potential must have a negative urine pregnancy test; Willing to have blood drawn: Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study: Unwilling to comply with study requirements; Renal impairment (serum creatinine >1.5 mg/dL); 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; Other contraindication to lithium, Patients who have had severe adverse reaction to Lithium; Patients who require inpatient care; Drug/alcohol dependence requiring immediate acute detoxification; Pregnancy as determined by serum pregnancy test or breastfeeding; History of nonresponse to lithium at doses ≥ 900 mg/d for ≥ 8 weeks; Unwilling to have blood drawn Patients with chronic medical conditions such as diabetes, coronary artery disease, immune diseases, infectious diseases and neurological disorders; 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. Currently on lithium

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lithium<br>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 | Drug: Lithium<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Expression of  45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium | Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a >=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a >=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed. | Baseline and Week 16 |