Phase 4 Depression and Anxiety Trial, Recruiting NCT05004987 Sponsor: NYU Langone Health Condition: Depression and Anxiety
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Phase 4 Depression and Anxiety Trial, Recruiting

NCT05004987
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 60 years or older at the time of signing the consent form
  • People who have been diagnosed with Major Depressive Disorder (a type of serious depression), confirmed through a structured clinical interview
  • People whose depression scores at least 18 on a standard depression rating scale used by doctors
  • People whose physical exam, neurological exam, vital signs, and heart tracing (EKG) results are within normal ranges at the screening visit
  • People whose memory and thinking abilities are within normal range, based on standard cognitive tests at screening
  • People who score within the normal range on a standard memory test (confirm with trial site for exact score details)
  • People who are fluent in English and able to read at approximately a 6th grade level
  • People who are generally medically stable, with no significant brain, nerve, or body conditions expected to affect the study
  • People with sufficient hearing and normal or corrected vision
  • People willing to undergo a brain MRI, urine drug test, routine blood tests, a lumbar puncture (spinal tap), a gene test, and blood level checks for study medication
  • People whose routine laboratory (blood and urine) test results are normal or show only minor, non-concerning abnormalities

Who may not be able to join:

  • People with a history of brain tumours, significant brain injury, hydrocephalus (fluid on the brain), seizures, or significant white matter changes seen on MRI
  • People with an intellectual disability or serious neurological conditions such as Parkinson's disease or other movement disorders
  • People with more than a moderate level of white matter changes on brain scans, as measured by a standard medical scale
  • People with a significant history of alcohol or drug misuse in the past 2 years, or those who meet diagnostic criteria for other psychiatric conditions such as schizophrenia, bipolar disorder, or any psychotic disorder (note: recurrent depression and anxiety disorders do not exclude someone)
  • People currently assessed as having a significant risk of suicide based on a standard rating scale
  • People with insulin-dependent diabetes
  • People with significant or unstable heart, lung, hormone, or blood-related conditions
  • People with implanted medical devices (such as a pacemaker or surgical clips) that would make an MRI unsafe
  • People who test positive for illicit drugs on a urine drug screen
  • People who have previously had a poor response to, poor tolerance of, or are currently being treated with the antidepressant escitalopram
  • People currently taking the antidepressant fluoxetine
  • People taking certain medications that are not permitted under the study protocol, including:
    • Certain Parkinson's disease medications (such as carbidopa/levodopa, amantadine, bromocriptine, pergolide, or selegiline)
    • Medications used for memory or dementia (cholinesterase inhibitors or memantine)
    • Regular aspirin use at any dose, unless the person is on low-dose aspirin for prevention purposes and is willing to pause it briefly before blood draws
    • Regular use of anti-inflammatory pain medications (NSAIDs) or antihistamines, unless the person is willing to pause them briefly before blood draws
    • Certain prescribed medications affecting mood or the nervous system (such as opioids, amphetamines, or cannabinoids) may be permitted if the dose has been stable for at least one month before the study starts (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Nunzio Pomara, MD, NYU Langone Health

Phone: 845-398-6532

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
4 February 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker Levels; Change in Cerebrospinal Fluid (CSF) Aβ42 Biomarker Levels; Change in Vascular Dysfunction (VD) Biomarker Levels; Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov