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Brain scans and blood tests could reveal who benefits from lithium

NCT ID NCT06396312

Knowledge-focused Sponsor: Max-Planck-Institute of Psychiatry Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 09, 2026 · Last updated Oct 09, 2026

Summary

Researchers at the Max Planck Institute of Psychiatry are studying whether combining brain imaging, EEG, blood tests, and cognitive assessments can predict which people with treatment-resistant depression respond to lithium. The study enrolls 130 adults with major depressive disorder who have not improved after at least one antidepressant and for whom lithium augmentation is clinically indicated. Participants undergo detailed clinical and biological testing, and researchers use machine learning to look for a pattern that might forecast response. The study does not assign treatment; patients and their doctors decide on lithium as part of routine care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the signature works, doctors could one day estimate who is likely to benefit from lithium before starting it, sparing others from a treatment that may not help.
What could go wrong
This is an observational study, not a test of whether lithium works. The signature may fail to predict response accurately, and it may not apply to patients outside this group.

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

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

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

patients treated at MPIP

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Obligated Participation in "Biobanking" of Max Planck Institute of psychiatry * Age: ≥18 years * DSM-V diagnosis of major depressive disorder (MDD; confirmed by Mini-Interview) * Treatment resistant depression (TRD): TRD stage I or TRD stage II * Indication for antidepressant pharmacotherapy * Indication for lithium augmentation * Ability to provide informed consent Exclusion Criteria: * Age: \< 18 years * Medical conditions incompatible with lithium therapy * History of hypomanic or manic episode * Two or more antidepressant substances simultaneously to lithium, except the combination with sleep-promoting antidepressants like Mirtazapine, Mianserin, or Trazodone * An alternative pharmacological augmentation strategy simultaneously to lithium disorder * Quetiapine immediate- and extended release more than 100 mg in total * Current substance use disorder except for moderate alcohol or benzodiazepine use bound to the current episode, or smoking * Patients who are not suitable for the study in the opinion of the investigator * Patients with a relevant comorbidity of the central nervous system such as focal neurological disease (stroke, tumour), current or past epilepsy, CNS inflammation including autoimmune disease, traumatic brain injury, past brain surgery * Patients that are not able to provide informed consent * Electroconvulsive therapy (ECT) in the current depressive episode * Repetitive transcranial magnetic stimulation (rTMS) in the current depressive episode

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Conditions

The condition(s) this trial relates to.

depressive disorder follicular lymphoma major depressive disorder Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, major, moderate Depressive disorder, major, recurrent, with psychotic symptoms Depressive disorder, major, recurrent, without psychotic symptoms Depressive disorder, major, severe Depressive disorder, treatment-resistant, class I or II Depressive; disorder, major, single episode, major (without psychotic symptoms) Depressive; disorder, major, single episode, major, with psychotic symptoms

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Max Planck Insitute of Psychiatry

    RECRUITING

    Munich, Bavaria, 80804, Germany

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