Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02909504
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02909504
Study Brief:
Protocol Section:
NCT02909504