NCT02909504

Gao NARASD Lithium Study

Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Keming Gao · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-09-21
• Last updated: 2020-07-10
• Results posted: 2020-07-10

Locations

1 site across 1 country: United States