Phase 4 Depression and Anxiety Trial, Recruiting NCT06218030 Sponsor: Queen's University Condition: Depression and Anxiety
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Phase 4 Depression and Anxiety Trial, Recruiting

NCT06218030
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:

  • Adults (18 years of age or older)
  • People who have been taking a specific type of antidepressant — either an SSRI or SNRI — at a steady, unchanged dose for at least 8 weeks
  • People with Generalised Anxiety Disorder (GAD) that has not improved after trying at least two different anxiety medications from two different medication groups, where each medication was taken for at least 8 weeks at an appropriate dose

Who may not be able to join:

  • People with moderate to severe depression, based on a specific questionnaire score of 15 or above out of 27 (confirm with trial site)
  • People assessed as having a moderate to high risk of suicide, or where suicide is considered likely in the near future, or who are currently showing suicidal behaviour — based on a structured interview tool
  • People who have been diagnosed with OCD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities, dementia, epilepsy, or other serious neurological conditions
  • People with heart or blood vessel disease, active infections, inflammatory conditions, a recent surgery, a recent physical injury, or other health conditions that could affect certain blood test results (specifically CRP or homocysteine levels)
  • People who use cannabis or cannabis products, illicit drugs, or who drink more than 3 alcoholic drinks per week
  • People who take vitamin supplements or natural health products that may affect anxiety or depression symptoms
  • People whose reading level is below a Grade 5 standard
  • People who are not able to go through the informed consent process independently

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 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Queen's University
Registry
ClinicalTrials.gov
Start date
22 October 2024
Est. completion
1 April 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Incidence of treatment-emergent adverse events; Incidence of treatment-emergent side effects measured with the ASEC; Response to treatment defined by CGI-I score below 3

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: 20 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