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NCT03336918Completed

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

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
81 (actual)
First submitted
5 Oct 2017
Start date
7 Dec 2017
Primary completion date
30 Jun 2025
Lead sponsor
Brigham and Women's Hospital
NCT number
NCT03336918

What you commit to

  • Study type: Observational
  • Participants enrolled: 81
  • From 7 Dec 2017 to the primary completion date, 30 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • metallic implants or other contraindications to MRI.
  • metallic implants or other contraindication to MRI.

Other illness

  • meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as
  • serious medical or neurological illness;

Age

  • under 18 years of age;

Other

  • 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;
  • current pregnancy or breast feeding;
  • pregnant or breast-feeding;

Who the study is looking for

  • 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.
  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic Foundation Center for Behavioral Health
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.