Precision Depression Adalimumab Trial

NCT07845604 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 25-1129 (858855)Young Investigator Grant
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Does adalimumab improve the symptoms of some patients with MDD who are already taking an anti-depressant?
2. 2.What characteristics predict for whom adalimumab has anti-depressant properties.
3. 3.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)
4. 4.Complete short (\<5 min) daily surveys for the 57 day duration of the study.

Conditions

Major Depressive Disorder (MDD)

Keywords

inflammation; depression; psychoneuroimmunology; intensive longitudinal study

Outcome Measures

Primary Outcomes (1)

• Change from baseline in individual somatic, affective, and motivational depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS)

  The QIDS (Trivedi et al., 2004; Rush et al., 2003) is a rating scale that assesses the nine criterion symptom domains designated by the American Psychiatric Association's (2000) DSM-IV to diagnose a major depressive episode. There are 16 items in the adult versions of the QIDS16 measuring the nine criterion symptom domains (sleep, sad mood, appetite/weight, concentration/decision making, self-view, thoughts of death or suicide, general interest, energy level, and restlessness/agitation) that define a major depressive episode according to the DSM-IV. The scores for three domains (sleep, appetite/weight, and restlessness/agitation) are based upon the maximum score (most pathological) of two or more questions for the total score analysis. Each of the remaining domains is rated by a single item. All domains are scored from 0 to 3, with higher scores reflecting greater psychopathology. Source: Yeung, A. et al. (2012). The QIDS. The Journal of nervous and mental disease, 200(8), 712-715.

  From start of trial to the end of study (Day 57)

Secondary Outcomes (1)

• Change from baseline in the total depression score, as measured by the Quick Inventory of Depressive Symptomatology

  From start of trial to the end of study (Day 57)

Study Arms (2)

Active Treatment Arm

EXPERIMENTAL

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

Drug: Adalimumab Biosimilars Injection

Placebo Comparison Arm

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Adalimumab Biosimilars Injection DRUG

adalimumab biosimilar 100mg/mL

Active Treatment Arm

Placebo OTHER

placebo injection of same volume as active medication for that visit

Also known as: saline placebo

Placebo Comparison Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding
• Active, chronic or recurrent infection
• Known malignancy
• Current use of immune modulating medications
• 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
• Symptomatic hyponatremia
• Monoamine oxidase inhibitors (MAOI) use within 14 days
• Recent use of Rituxan (rituximab)
• Concomitant use of:
• Immunosuppressants
• Kineret (anakinra)

Sponsors & Collaborators

• Daniel Moriarity: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (2)

• Menter A, Augustin M, Signorovitch J, Yu AP, Wu EQ, Gupta SR, Bao Y, Mulani P. The effect of adalimumab on reducing depression symptoms in patients with moderate to severe psoriasis: a randomized clinical trial. J Am Acad Dermatol. 2010 May;62(5):812-8. doi: 10.1016/j.jaad.2009.07.022. Epub 2010 Mar 9.

  PMID: 20219265 BACKGROUND

• Abbasian F, Bagheri S, Moradi K, Keykhaei M, Etemadi A, Shalbafan M, Shariati B, Vaseghi S, Samsami FS, Akhondzadeh S. Evidence for Anti-inflammatory Effects of Adalimumab in Treatment of Patients With Major Depressive Disorder: A Pilot, Randomized, Controlled Trial. Clin Neuropharmacol. 2022 Sep-Oct 01;45(5):128-134. doi: 10.1097/WNF.0000000000000518. Epub 2022 Sep 7.

  PMID: 36093920 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Inflammation; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Daniel P. Moriarity, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel P Moriarity, PhD

CONTACT

(484) 808-5930; dmori@upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data necessary to reproduce analyses will be shared with reviewers before publication and available after in perpetuity
• Access Criteria: open access after publication

Locations

US (1)