Brain scans reveal Lithium's secret workings in bipolar depression
NCT ID NCT03336918
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study looks at how lithium, a common treatment for bipolar disorder, affects the brain's wiring. Researchers will use MRI scans to track changes in brain connections over 26 weeks in 120 adults with bipolar depression. The goal is to understand why lithium works, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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81 people
The number who actually took part.
- Started
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Dec 2017
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Bipolar disorder and healthy controls
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, 44195, United States
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