Add-on anti-inflammatory therapy for adults with depression and high inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, triple-blind, placebo-controlled trial examines adalimumab as an add-on treatment to escitalopram in adults with Major Depressive Disorder and elevated TNF levels. Participants are randomized 2:1 to receive active adalimumab or placebo over 57 days, with injections on days 1, 15, 29, and 43 and biweekly clinic visits. Daily brief mood surveys track symptoms during the study, and clinicians assess outcomes at visits. The trial seeks to identify which patients benefit and what characteristics predict an antidepressant response to the anti-inflammatory approach. Eligibility requires confirmed MDD, stable Lexapro use, adequate contraception for potential females, and detectable inflammation (TNF-alpha > 1.5 pg/mL).

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Daniel P. Moriarity, PhD — University of Pennsylvania
• Study coordinator: Daniel P Moriarity, PhD
• Email: dmori@upenn.edu
• Phone: (484) 808-5930

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Emotional Reactivity in Severe Alcohol Use Disorder and Depression Using Eye-Tracking and Physiological Measures

  This study tests how people with severe alcohol use disorder, major depressive disorder, both conditions, or neither, recognize and react to emotions using eye-tracking and physiological data.

  Recruiting Université Catholique de Louvain · Brussels, Belgium · NCT07925281

• Temporally Interfering Electrical Stimulation for Major Depressive Disorder

  This study tests whether noninvasive temporally interfering electrical stimulation can help people with major depressive disorder.

  Recruiting at 2 sites Tianjin Medical University General Hospital · Fuzhou, Fujian and 1 other locations · NCT07924917

• Affective Cognitive Training for mood disorders and their close relatives

  A six-week program combining virtual reality and computer exercises tests whether affective cognitive training helps people with mood disorders and their unaffected first-degree relatives.

  Recruiting Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Frederiksberg, Capital Region of Denmark · NCT07920302

• ALKS 7290 added to antidepressants for adults with major depression

  This study tests whether ALKS 7290, taken with current antidepressants, helps adults with major depressive disorder.

  Recruiting Phase 2 Alkermes, Inc. · Jacksonville, Florida · NCT07901179

• French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

  This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.

  Recruiting at 10 sites Fondation FondaMental · Besançon and 16 other locations · NCT07881016

• EEG-Guided TMS for Adults With Depression

  This study tests whether delivering intermittent theta burst stimulation (iTBS) timed to brain waves using EEG can improve treatment for adults with major depressive disorder who have not responded to usual antidepressants.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07862205

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.