Clinical trial NCT02909504: Gao NARASD Lithium Study
Official title: Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: CellPrint Biotechnology
name: National Alliance for Research on Schizophrenia and Depression
First posted: 2016-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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

Primary outcomes:
measure: Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
timeFrame: Baseline and Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center Department of Psychiatry
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Keming Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: