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NCT07845604RecruitingPhase 2

Precision Depression Adalimumab Trial

An Precision Immunopsychiatric Pharmacological Probe of Adalimumab as an Anti-depressant

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn if the anti-inflammatory medication adalimumab improves depressive symptoms in adults with Major Depressive Disorder (MDD) who are already taking the anti-depressant medication Lexapro (escitalopram). The main questions it aims to answer are: 1. Does adalimumab improve the symptoms of some patients with MDD who are already taking an anti-depressant? 2. What characteristics predict for whom adalimumab has anti-depressant properties. Researchers will compare adalimumab to a placebo (a look-alike substance that contains no drug) to see if adalimumab works to improve depressive symptoms as an add-on drug to the anti-depressant Lexapro (escitalopram). For these primary aims the participants will: 1. Visit the clinic once every 2 weeks for a checkups and injection of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections) 2. Complete short (\<5 min) daily surveys for the 57 day duration of the study.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Sept 2026
Start date
1 Sept 2026
Primary completion date
31 Jul 2031
Lead sponsor
Daniel Moriarity
Diseases
Depression
NCT number
NCT07845604

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 1 Sept 2026 to the primary completion date, 31 Jul 2031
  • 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

  • Current use of immune modulating medications
  • Monoamine oxidase inhibitors (MAOI) use within 14 days
  • Concomitant use of:
    • Immunosuppressants
    • Kineret (anakinra)
    • Orencia (abatacept)
    • Remicade (infliximab)
    • Enbrel (etanercept)
    • Cimzia (certolizumab pegol)
    • Simponi (golimumab)
    • Imuran (azathioprine)
    • Purinethol (6-mercaptopurine)
    • Linezolid
    • IV methylene blue
    • Pimozide
    • Antiplatelet agents
    • Strong anticoagulants (e.g. warfarin, large doses of NSAIDs)
    • Other SSRIs, SNRIs, tryptophan
  • Treatment with another investigational drug or other intervention while participating in the study

Other illness

  • Active, chronic or recurrent infection
  • Known malignancy
  • Immunocompromised, current autoimmune condition or history of severe immune condition (e.g., history of cancer, HIV/AIDS)
  • History of, or positive test for, Hepatitis B surface antigen or core antibody positivity or tuberculosis (TB)
  • Congestive heart failure
  • History of demyelinating disease (multiple sclerosis (MS), optic neuritis, Guillain-Barre syndrome)
  • History of seizure disorder
  • Clinically relevant substance use disorder
  • Known allergic reactions to components of adalimumab and/or escitalopram

Other

  • Pregnant or breastfeeding
  • Symptomatic hyponatremia
  • Recent use of Rituxan (rituximab)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept 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
University of Pennsylvania
Coordinator of this site? Confirm its status		PhiladelphiaUnited StatesRecruiting

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