Investigating how lithium affects brain connectivity in bipolar disorder

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

This study is testing how lithium treatment affects brain connections in people with bipolar disorder to see if it helps improve their mood and mental health.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT03336918 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the effects of lithium monotherapy on the brain's structural and functional connectivity in individuals with bipolar disorder. Using MRI imaging, the study will assess how lithium influences brain network properties and their relationship to behavioral outcomes such as mood stability and depression. Additionally, it will investigate the molecular effects of lithium by measuring gene expression changes. The goal is to understand the connection between brain changes and improvements in mental health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of bipolar disorder I or II experiencing a current depressive episode.

Not a fit: Patients with primary diagnoses of schizophrenia, schizoaffective disorder, or anxiety disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of how lithium treatment improves outcomes for patients with bipolar disorder.

How similar studies have performed: While lithium has been widely studied, this specific approach using network properties and gene expression is novel and has not been extensively tested.

Eligibility criteria

Inclusion criteria for BD subjects:

* ages 18-60 years (inclusive) and able to give voluntary informed consent;
* Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for BD I or II, current Depressive Episode;
* 17-item Hamilton Depression Rating Scale (HAM-D) score \>15 and \<25;
* Young Mania Rating Scale (YMRS) \< 8;
* no psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for 5 weeks) OR on stable psychotropic medications for 12 weeks
* no lithium treatment for past 6 months;
* satisfy criteria to undergo an MRI scan based on MRI screening questionnaire;
* able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale \< 5 (i.e., moderately ill) and no significant suicidal or homicidal ideation or gross disability.

Exclusion criteria for BD subjects are:

* meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as
* a primary diagnosis;
* requiring inpatient treatment;
* meeting DSM-V criteria for substance dependence within the past 3 months, except caffeine or nicotine;
* positive urinary toxicology screening at screening visit;
* use of alcohol in the past 1 week;
* serious medical or neurological illness;
* current pregnancy or breast feeding;
* metallic implants or other contraindications to MRI.

Inclusion criteria for healthy subjects:

* ages 18-60 years and ability to give voluntary informed consent;
* no history of psychiatric illness or substance abuse or dependence;
* no significant family history of psychiatric or neurological illness in first degree relative;
* not currently taking any prescription or centrally acting medications;
* no use of alcohol in the past 1 week;
* and no serious medical or neurological illness.

Exclusion criteria for healthy subjects are:

* under 18 years of age;
* pregnant or breast-feeding;
* metallic implants or other contraindication to MRI.

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation Center for Behavioral Health — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Amit Anand, MD — The Cleveland Clinic
• Study coordinator: Lauren A Patton

Conditions Bipolar Disorder; Bipolar I Depression; Bipolar II Depression; Bipolar Depression; Depression; Major Depressive Episode; Bipolar I and II Depression; Lithium