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Can an arthritis drug lift depression? scientists put adalimumab to the test

NCT ID NCT07845604

Symptom relief Sponsor: Daniel Moriarity Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 29, 2026 · Last updated Sep 30, 2026 · Updated 1 time

Summary

Researchers are testing whether adalimumab, an anti-inflammatory antibody drug, eases depressive symptoms in adults with major depressive disorder who already take the antidepressant escitalopram. The trial enrolls 60 adults aged 18 and older who have elevated blood levels of an inflammation marker called TNF-alpha. Participants receive either adalimumab or a saline placebo injection every two weeks for about two months and complete short daily surveys, so researchers can see whether the drug helps and which characteristics predict a response.

What this could mean

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

Active substance
adalimumab, an anti-inflammatory antibody drug given as an injection
What this could lead to
If it works, adalimumab could offer a new add-on option for people whose depression does not fully respond to standard antidepressants, and blood markers of inflammation might help predict who benefits.
What could go wrong
This is a small Phase 2 trial of 60 people, so any benefit may be modest or may not hold up in larger studies. Adalimumab suppresses the immune system and can raise the risk of infections, and it may turn out to help only a narrow subgroup defined by high inflammation.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

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.

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: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18+ years * Meet DSM-5 criteria for Major Depressive Disorder * baseline serum TNF-alpha (average of two samples in the same week) greater than 1.5 pg/mL * Taking a steady dose of Lexapro (escitalopram) for at least 4 weeks * Ability to take oral medication and physician-administered subcutaneous injection and be willing to adhere to the study protocol * For females of reproductive potential: use of highly effective contraception for at least 1 month * Access to a phone or computer with a camera Exclusion Criteria: 1. Pregnant or breastfeeding 2. Active, chronic or recurrent infection 3. Known malignancy 4. Current use of immune modulating medications 5. Immunocompromised, current autoimmune condition or history of severe immune condition (e.g., history of cancer, HIV/AIDS) 6. History of, or positive test for, Hepatitis B surface antigen or core antibody positivity or tuberculosis (TB) 7. Congestive heart failure 8. History of demyelinating disease (multiple sclerosis (MS), optic neuritis, Guillain-Barre syndrome) 9. History of seizure disorder 10. Symptomatic hyponatremia 11. Monoamine oxidase inhibitors (MAOI) use within 14 days 12. Recent use of Rituxan (rituximab) 13. Concomitant use of: 1. Immunosuppressants 2. Kineret (anakinra) 3. Orencia (abatacept) 4. Remicade (infliximab) 5. Enbrel (etanercept) 6. Cimzia (certolizumab pegol) 7. Simponi (golimumab) 8. Imuran (azathioprine) 9. Purinethol (6-mercaptopurine) 10. Linezolid 11. IV methylene blue 12. Pimozide 13. Antiplatelet agents 14. Strong anticoagulants (e.g. warfarin, large doses of NSAIDs) 15. Other SSRIs, SNRIs, tryptophan 14. Clinically relevant substance use disorder 15. Known allergic reactions to components of adalimumab and/or escitalopram 16. Treatment with another investigational drug or other intervention while participating in the study

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Conditions

The condition(s) this trial relates to.

Depression Inflammation major depressive disorder

As listed by the trial registrant

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

Major depressive disorder (MDD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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