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Brain scans reveal Lithium's secret workings in bipolar depression

NCT ID NCT03336918

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

81 people

The number who actually took part.

Started

Dec 2017

Finished

Jun 2025

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Cleveland Clinic Foundation Center for Behavioral Health

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.