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Gao NARASD Lithium Study

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lithium
Sponsored by
Keming Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bipolar Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center Department of Psychiatry

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lithium

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2016
Last Updated
June 12, 2020
Sponsor
Keming Gao
Collaborators
CellPrint Biotechnology, National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT02909504
Brief Title
Gao NARASD Lithium Study
Official Title
Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Keming Gao
Collaborators
CellPrint Biotechnology, National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lithium
Arm Type
Other
Arm 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 Type
Drug
Intervention Name(s)
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
Primary Outcome Measure Information:
Title
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Description
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.
Time Frame
Baseline and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keming Gao, MD, PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center Department of Psychiatry
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gao NARASD Lithium Study

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