Major Depressive Disorder (MDD)Phase 2PDATNCT07845604
Precision Depression Adalimumab Trial
A Phase 2 study testing Adalimumab Biosimilars Injection in people with Major Depressive Disorder (MDD), run by Daniel Moriarity at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Adalimumab Biosimilars Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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)
- 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
- Clinically relevant substance use disorder
- Known allergic reactions to components of adalimumab and/or escitalopram
- Treatment with another investigational drug or other intervention while participating in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Daniel P. Moriarity, PhD, (484) 808-5930, dmori@upenn.edu
About this study
Official title: An Precision Immunopsychiatric Pharmacological Probe of Adalimumab as an Anti-depressant
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:
Read more
- Does adalimumab improve the symptoms of some patients with MDD who are already taking an anti-depressant?
- 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:
- 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)
- Complete short (<5 min) daily surveys for the 57 day duration of the study.
Read the detailed description
This is a 57-day intensive longitudinal study of 60 adult subjects with Major Depressive Disorder and elevated baseline tumor necrosis factor (TNF) levels. A triple-blind, placebo-controlled pharmacological investigation of adalimumab as an adjunctive medication to escitalopram will be conducted to determine anti-depressant efficacy of adalimumab. Patients will be screened for depression, health concerns, and a minimum of 1.5 pg/mL TNFa. It is hypothesized that adalimumab will lead to improved treatment outcomes (specifically somatic/neurovegetative symptoms). It is hypothesized that, if more symptoms than somatic/neurovegetative respond, they will do so less quickly than somatic/neurovegetative symptoms.
Enrolled participants will be randomized in a 2:1 ratio to adjunctive adalimumab or placebo in addition to the participant's regular dose of escitalopram each day (both conditions). Patients will be matched for sex. Enrolled patients will attend 4 clinic visits, at which point they will receive injections of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections), in addition to clinician-assessed measures. Daily self-report assessments of depression symptoms will be collected for 57 days.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Adalimumab Biosimilars Injection, Placebo
- Keywords
- inflammation, depression, psychoneuroimmunology, intensive longitudinal study
- Medical subject headings
- Depressive Disorder, Major, Inflammation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab Biosimilars InjectionDrug
adalimumab biosimilar 100mg/mL
PlaceboOther
Also called saline placebo
placebo injection of same volume as active medication for that visit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
as for primary
Measured: From start of trial to the end of study (Day 57)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Moriarity
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Sponsor-investigator, Daniel Moriarity, University of Pennsylvania
- Investigators
- Daniel P. Moriarity, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845604
- Sponsor's protocol ID
- 25-1129 (858855)
- Other IDs
- Young Investigator Grant
- Acronym
- PDAT
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication-specific
Publications
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.
PubMed 20219265Abbasian 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.
PubMed 36093920
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Precision Immunopsychiatric Pharmacological Probe of Adalimumab as an Anti-depressant
- ClinicalTrials.gov ID
- NCT07845604
- Acronym / sponsor ID
- PDAT / 25-1129 (858855)
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- inflammation, depression, psychoneuroimmunology, intensive longitudinal study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daniel MoriarityUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does adalimumab improve the symptoms of some patients with MDD who are already taking an anti-depressant?
- 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:
- 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)
- Complete short (<5 min) daily surveys for the 57 day duration of the study.
Detailed description
This is a 57-day intensive longitudinal study of 60 adult subjects with Major Depressive Disorder and elevated baseline tumor necrosis factor (TNF) levels. A triple-blind, placebo-controlled pharmacological investigation of adalimumab as an adjunctive medication to escitalopram will be conducted to determine anti-depressant efficacy of adalimumab. Patients will be screened for depression, health concerns, and a minimum of 1.5 pg/mL TNFa. It is hypothesized that adalimumab will lead to improved treatment outcomes (specifically somatic/neurovegetative symptoms). It is hypothesized that, if more symptoms than somatic/neurovegetative respond, they will do so less quickly than somatic/neurovegetative symptoms.
Enrolled participants will be randomized in a 2:1 ratio to adjunctive adalimumab or placebo in addition to the participant's regular dose of escitalopram each day (both conditions). Patients will be matched for sex. Enrolled patients will attend 4 clinic visits, at which point they will receive injections of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections), in addition to clinician-assessed measures. Daily self-report assessments of depression symptoms will be collected for 57 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Arm | Experimental | Drug: Adalimumab Biosimilars Injection80 mg adalimumab administered on Day 1 subcutaneously, then 40 mg adalimumab administered on Days 15, 29, and 43 subcutaneously by study psychiatrist. |
| Placebo Comparison Arm | Placebo comparator | Other: Placebo0.8 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (31 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab Biosimilars Injectionadalimumab biosimilar 100mg/mL | Drug | Active Treatment Arm |
| PlaceboAlso: saline placeboplacebo injection of same volume as active medication for that visit | Other | Placebo Comparison Arm |
Primary outcome
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)
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.
1 secondary outcome
Change from baseline in the total depression score, as measured by the Quick Inventory of Depressive Symptomatology
Time frame: From start of trial to the end of study (Day 57)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 20219265Menter 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.
- Background: PubMed 36093920Abbasian 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.
- Individual participant dataSharing planned: Yes. Publication-specific
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel P. Moriarity, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab Biosimilars Injection in people with Major Depressive Disorder (MDD), run by Daniel Moriarity at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel P Moriarity, PhD ((484) 808-5930, dmori@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07845604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.