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RecruitingPhase 2

Precision Depression Adalimumab Trial

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Time periods mentioned: 57 days
  • Procedures mentioned: Injections, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adalimumab, a drug that lowers inflammation, helps adults with major depression who already take Lexapro (escitalopram). Researchers will compare adalimumab with a placebo, a look-alike shot with no drug, and look for clues about who may benefit.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have a diagnosis of major depressive disorder.
  • Sign a consent form and agree to follow study steps for all 57 days.
  • Have an average blood level of TNF-alpha, a sign of inflammation, above 1.5 pg/mL on two tests in the same week.
  • Have taken the same dose of Lexapro (escitalopram) for at least 4 weeks.
  • Be able to take pills and receive shots under the skin from a doctor.
  • If you can become pregnant, have used highly effective birth control for at least 1 month.
  • Have access to a phone or computer with a camera.
  • Be available for clinic visits every 2 weeks and daily surveys that take less than 5 minutes.

Who can't join

  • You are pregnant or breastfeeding.
  • You have an active, long-lasting, or repeated infection; or a history of, or positive test for, hepatitis B or tuberculosis (TB).
  • You have cancer, a weakened immune system, an illness where the immune system attacks the body, or a past severe immune condition, such as cancer or HIV/AIDS.
  • You have heart failure, a past seizure disorder, low blood sodium that causes symptoms, or a history of nerve-covering diseases such as multiple sclerosis, optic neuritis, or Guillain-Barre syndrome.
  • You take medicines that change or weaken the immune system; recently took Rituxan (rituximab); or took an MAOI antidepressant within 14 days.
  • You take any of these: Kineret, Orencia, Remicade, Enbrel, Cimzia, Simponi, Imuran, Purinethol, linezolid, IV methylene blue, pimozide, antiplatelet drugs that prevent blood clots, strong blood thinners such as warfarin, large doses of NSAID pain medicines, other SSRI or SNRI antidepressants, or tryptophan.
  • You have a substance use disorder that matters for your care, or a known allergy to ingredients in adalimumab or escitalopram.
  • You receive another experimental drug or study treatment while taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

PA