Phase 3 Depression and Anxiety Trial, Recruiting NCT07227454 Sponsor: Janssen Research & Development, LLC Condition: Depression and Anxiety
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Phase 3 Depression and Anxiety Trial, Recruiting

NCT07227454
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:

  • People who have been diagnosed with major depressive disorder (a serious form of depression) based on a clinical assessment and a standardised interview tool
  • People whose suicidal thoughts or behaviour have been rated as "markedly" severe or higher on a standard rating scale at two separate visits (screening and baseline)
  • People whose depression symptoms score at or above a certain level on a standard children's depression rating scale at the baseline visit
  • People whose doctor believes they need to be admitted to a psychiatric hospital because of the seriousness of their suicidal state
  • People who are in stable physical health, confirmed by a physical check-up, medical history review, vital signs measurement, and a heart tracing (ECG) done at screening

Who may not be able to join:

  • People who have a current diagnosis of bipolar disorder or related conditions, intellectual disability, autism spectrum disorder, conduct disorder, or oppositional defiant disorder
  • People who currently meet the criteria for borderline personality disorder
  • People who have a current or past diagnosis of a psychotic disorder, or depression with psychotic features
  • People who have a history of seizure disorder (epilepsy or similar conditions)
  • People who have known allergies, sensitivities, intolerances, or medical reasons to avoid the study medications midazolam, esketamine, or ketamine, or any of their ingredients

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 14 July 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.

Contact this trial

Phone: 844-434-4210

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 3
Registry
ClinicalTrials.gov
Start date
8 January 2026
Est. completion
9 April 2031

Where this trial is recruiting

🇧🇷 Brazil 🇭🇺 Hungary 🇮🇹 Italy 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose

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: 14 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