drugset / Trial / NCT02909504
Gao NARASD Lithium Study
Phase 4
Terminated
24 enrolled
Keming Gao
CellPrint Biotechnology · collabNational Alliance for Research on Schizophrenia and Depression · collab
NaSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2016-09
- Primary completion
- 2018-11
- Completion
- 2018-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lithium | Unknown | — | — |