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

NCT03336918 | Active Not Recruiting FDA Drug

• 1 other identifier: 17-441
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Bipolar Disorder; Bipolar I and II Depression; Lithium; Depression

Outcome Measures

Primary Outcomes (2)

• Functional Connectivity (Fc) changes

  Investigate effects of lithium monotherapy treatment of BD on changes in Fc through fMRI imaging from baseline after 2, 8, and 26 weeks of treatment and test whether these changes correlate with improvement in state-related symptoms and longer term mood stability. Healthy controls will also be scanned at the same time points but not treated.

  2, 8, 26 weeks

• Structural Connectivity (Sc) changes

  Investigate effects of lithium monotherapy treatment of BD depression on changes in the diffusion weighted imaging Sc through fMRI imaging from baseline after 2, 8, and 26 weeks and test whether these changes correlate with depression severity and mood stability. Healthy controls will also be scanned at the same time points but not treated.

  2, 8, 26 weeks

Secondary Outcomes (1)

• Changes in peripheral gene expression

  2, 8, 26 weeks

Study Arms (2)

Bipolar Disorder I or II Depressed

DSM-V Bipolar I or II Depressed treated with lithium

Drug: Lithium

Healthy Controls

Healthy Controls with no psychiatric history

Interventions

Lithium DRUG

Open-label lithium treatment for Bipolar Disorder Subjects Healthy Controls only repeat testing - no intervention

Also known as: Lithium carbonate or citrate or Lithium extended release

Bipolar Disorder I or II Depressed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Bipolar disorder and healthy controls

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gene Expression RNA sequencing

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Lithium; Lithium Carbonate; Citric Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Amit Anand, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: November 8, 2017
• Study Start: December 7, 2017
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-06

Locations

US (1)