Phase 3 Depression and Anxiety Trial, Recruiting NCT05644301 Sponsor: Universiteit Antwerpen Condition: Depression and Anxiety
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Phase 3 Depression and Anxiety Trial, Recruiting

NCT05644301
Recruiting Phase 3

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:

  • You are between 18 and 65 years old (inclusive)
  • You are able and willing to give your consent to take part and can take medication by mouth
  • You are in generally good physical health
  • You have been diagnosed with Major Depressive Disorder (clinical depression) confirmed by a standard psychiatric interview
  • Your current episode of depression has not improved enough with your current antidepressant, or you have had a relapse of depression while taking it
  • You are tolerating your current antidepressant well and do not plan to change your treatment during the study
  • You have been on your current antidepressant at a stable dose for at least 4 weeks (or 6 weeks if you take fluoxetine) before the study starts
  • If you are a woman who could become pregnant, you are willing to use reliable contraception and take a pregnancy test at the start of the study

Who may not be able to join:

  • You have a primary diagnosis of bipolar disorder, a psychotic disorder, obsessive-compulsive disorder, an eating disorder, PTSD, or an alcohol or substance use disorder within the past 4 weeks (excluding nicotine or caffeine use)
  • You have taken drugs that suppress or stimulate the immune system (such as steroids or methotrexate) within the past 21 days
  • You have a history of stomach ulcers or gastrointestinal (gut) bleeding
  • You currently have an active infection or inflammatory bowel condition
  • You have serious heart disease, heart failure, or unstable coronary artery disease (including recent bypass surgery)
  • You have significant liver problems (confirm with trial site for specific test values)
  • You have significant kidney problems (confirm with trial site for specific test values)
  • You have taken tetracycline antibiotics or anti-inflammatory painkillers (such as ibuprofen) for more than 14 days in the past 2 months, or you have a known sensitivity or intolerance to these types of drugs
  • You have chronically high blood pressure with a systolic reading above 170 mmHg
  • You have tested positive for Hepatitis B, Hepatitis C, or HIV
  • You have had electroconvulsive therapy (ECT) within the past 2 months
  • You have donated blood in the 30 days before the study starts
  • You are currently pregnant or breastfeeding
  • You are currently taking part in another intervention study

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 30 June 2026
Phase 3: approximately ~65% 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.

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Universiteit Antwerpen
Registry
ClinicalTrials.gov
Start date
21 September 2023
Est. completion
1 September 2026

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Change in depressive symptom severity (HDRS-17); Remission rate of depression (HDRS-17)

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: 30 June 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