Phase 4 Depression and Anxiety Trial, Recruiting
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.
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
Where this trial is recruiting
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?
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.