Phase 2 Depression and Anxiety Trial, Recruiting NCT04751331 Sponsor: Laureate Institute for Brain Research, Inc. Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT04751331
Recruiting Phase 2

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 18 to 65 years old who are in good general health
  • People without depression (healthy volunteers) who meet the general health requirements
  • People with a diagnosed depressive disorder (Major Depressive Disorder), confirmed using a structured clinical interview
  • People with depression who have a current depression symptom score at or above a certain threshold, as measured by standard questionnaires used by the clinical team

Who may not be able to join:

  • People who are pregnant
  • People with a history of fainting during blood draws (the clinical team will assess this on a case-by-case basis)
  • People who have had a moderate to severe traumatic brain injury (involving more than 30 minutes of unconsciousness or more than 24 hours of memory loss afterward), or any other condition causing measurable neurological damage
  • People with significant medical conditions such as a history of heart attack, stroke, Parkinson's disease, or ongoing pain disorders
  • People with inflammatory or autoimmune conditions such as rheumatoid arthritis
  • People with an uncontrolled medical condition that the research team believes could interfere with the study or pose a risk to participants
  • People with a chronic (long-term) infection that may raise inflammation levels in the body
  • People who have had an active infection or received a vaccine within the two weeks before a study session
  • People with current severe thoughts of suicide, or who have made a suicide attempt in the past 12 months
  • People with psychosis
  • People with bipolar disorder
  • People with a history of substance abuse or dependence within the past six months
  • People with certain metal implants or devices in or on their body that are not compatible with MRI scanning, including pacemakers, metal fragments, aneurysm clips, joint replacements, heart valves, cochlear implants, neurostimulators, and similar items (confirm with trial site for the full list)
  • People with severe claustrophobia that would prevent them from being in an MRI scanner
  • People who have regularly used hormone-containing medications (other than contraceptives), either currently or in the past
  • People currently using oral corticosteroids or other medications that suppress the immune system
  • People currently using anti-inflammatory medications such as ibuprofen more than three days per week, where the research team determines this could affect study results
  • People who currently use, or have regularly used in the past, medications that specifically target the immune system, such as TNF blockers
  • People currently using opioid pain medications, or with a history of addiction to opioids or other pain medications
  • People who currently use, or have regularly used in the past, heart or blood pressure medications — unless those medications are being taken for a different purpose such as migraine prevention (confirm with trial site)
  • People who regularly use certain long-term antibiotics, such as isotretinoin or minocycline, due to their potential effects on the gut and immune system
  • People whose urine test shows evidence of recreational drug use
  • People who have ever used methamphetamine
  • People using other medications or supplements not listed above may also be excluded, based on the lead researcher's assessment of whether those substances could affect immune function, the gut microbiome, brain function, or blood flow to the brain
  • People with a body mass index (BMI) above 35
  • People with significant abnormalities found on blood tests taken during screening
  • People with an abnormal heart tracing (EKG) at screening
  • People who, on the day of the study, have blood pressure, heart rate, heart rhythm measurements, or body temperature outside of the acceptable ranges set by the research team (confirm with trial site for specific values)
  • People who do not speak English, as most of the study assessments are only available in English

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 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 918 502 5104

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 2
Sponsor
Laureate Institute for Brain Research, Inc.
Registry
ClinicalTrials.gov
Start date
15 May 2021
Est. completion
1 April 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Inflammatory response

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: 28 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