Gao NARASD Lithium Study

NCT02909504 | Terminated Phase 4 Results DMC

• 1 other identifier: 07-16-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lithium

OTHER

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

Interventions

Lithium 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

Lithium

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Keming Gao: lead
• CellPrint Biotechnology: collaborator
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center Department of Psychiatry

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Results Point of Contact

• Title: Dr. Keming Gao, MD, PhD
• Organization: University Hospitals Cleveland Medical Center

keming.gao@UHhospitals.org

2168442865

Study Officials

• Keming Gao, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director, Mood Disorders Program, UH Cleveland Medical Center

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 10, 2020
• Results First Posted: July 10, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)