Gao NARASD Lithium Study

NCT ID: NCT02909504

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-11-30

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lithium

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

Group Type: OTHER

Lithium

Intervention Type: DRUG

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

Interventions

Lithium

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 Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CellPrint Biotechnology

OTHER

Sponsor Role: collaborator

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

Keming Gao

OTHER

Sponsor Role: lead

Responsible Party

Keming Gao

Clinical Director, Mood Disorders Program, UH Cleveland Medical Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Keming Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center Department of Psychiatry

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

07-16-05

Identifier Type: -

Identifier Source: org_study_id