NCT03336918

Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Lithium is highly effective in the treatment of bipolar disorder. This study aims to investigate, for the first time, the impact of lithium monotherapy on the structural and functional connectivity of the brain using MRI imaging.

Detailed description

The premise of this proposal is that the clinical efficacy of lithium in bipolar disorder, and its complex effects on multiple brain physiological functions, may be best deciphered using a network properties-metric approach. This approach is critical because it provides insight into the function of brain networks (e.g., resilience to disruption, central hubs), which is likely to be more closely linked to behavioral outcomes. Furthermore, we will conduct an exploratory investigation of the in vivo molecular effects of lithium by measuring peripheral gene expression. To bring these together, we will also explore whether connectome changes serve as mediator between molecular changes (i.e., gene expression) induced by lithium treatment and behavioral changes (e.g., depression, mood stability, suicidality).

Conditions

• Bipolar Disorder
• Bipolar I Depression
• Bipolar II Depression
• Bipolar Depression
• Depression
• Major Depressive Episode

Interventions

Type	Name	Description
DRUG	Lithium	Open-label lithium treatment for Bipolar Disorder Subjects Healthy Controls only repeat testing - no intervention

Timeline

• Start date: 2017-12-07
• Primary completion: 2025-06-30
• Completion: 2026-06-01
• First posted: 2017-11-08
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study