Recruiting
Phase 2

Adalimumab with Lexapro

Sponsor:

Daniel Moriarity

Code:

NCT07845604

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adalimumab Biosimilars Injection

Placebo

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07845604

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Jul, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Treatment Arm

80 mg adalimumab administered on Day 1 subcutaneously, then 40 mg adalimumab administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.

placebo comparator: Placebo Comparison Arm

0.8 mL saline placebo administered on Day 1 subcutaneously, then 0.4 mL saline placebo administered on Days 15, 29, and 43 subcutaneously by study psychiatrist.

Interventions

Adalimumab Biosimilars Injection

adalimumab biosimilar 100mg/mL

Placebo

placebo injection of same volume as active medication for that visit

Primary outcome measure

  • Change from baseline in individual somatic, affective, and motivational depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: From start of trial to the end of study (Day 57) ]

Central Contacts and Locations

Central contacts

Daniel P Moriarity, PhD

(484) 808-5930dmori@upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Daniel P. Moriarity, PhD

(484) 808-5930dmori@upenn.edu

More Information

Sponsor

Daniel Moriarity

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • inflammation
  • depression
  • psychoneuroimmunology
  • intensive longitudinal study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Daniel Moriarity on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.