Phase 2 Depression and Anxiety Trial, Recruiting NCT07639359 Sponsor: Hospital Italiano de Buenos Aires Condition: Depression and Anxiety
Back to Depression And Anxiety

Phase 2 Depression and Anxiety Trial, Recruiting

NCT07639359
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 99 years, of any gender
  • People who have been staying in an intensive care unit (ICU) for 6 or more days at the time of screening
  • People showing moderate to severe signs of depression, based on a standard questionnaire score of 10 or higher at the time of screening
  • People who are able to understand and agree to take part in the study (provide informed consent)

Who may not be able to join:

  • People with a history of psychosis or hallucinations, based on a review of their medical records and an interview during screening
  • People with a history of a heart condition involving a prolonged QT interval (an abnormal heart rhythm pattern)
  • People with a history of dementia
  • People who had a diagnosis of major depressive disorder before their current ICU stay
  • People with a history of certain mental health diagnoses, including dissociative disorder, primary psychotic disorder, mania with psychosis, pervasive developmental disorder, cognitive disorder, or anorexia nervosa
  • People with a known allergy to ketamine or diphenhydramine
  • People with a history of raised pressure in the brain or the eyes, or a condition called hypertensive hydrocephalus
  • People whose vital signs are unstable at the time of screening — for example, blood oxygen level, blood pressure, heart rate, or breathing rate that falls outside safe ranges
  • People who decline to take part or are unable to give informed consent
  • People who are pregnant, within 2 months after giving birth, or currently breastfeeding
  • People with a known mass or blood vessel abnormality in the brain
  • People whose mental state at the time of screening prevents them from giving informed consent
  • People whose body weight is below 45 kg or above 115 kg
  • People currently experiencing active psychosis
  • People currently taking certain medications that affect a specific brain receptor system, including lamotrigine, acamprosate, memantine, riluzole, or lithium
  • People currently taking aminophylline or theophylline
  • People currently going through withdrawal from a substance, or who have used hallucinogens — including cannabis — in the past month, as determined by interview and a urine test

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 15 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

Principal Investigator: Ivan A Huespe, MD, Hospital Italiano de Buenos Aires

Phone: +5493425382554

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
Hospital Italiano de Buenos Aires
Registry
ClinicalTrials.gov
Start date
14 May 2026
Est. completion
1 July 2027

Where this trial is recruiting

🇦🇷 Argentina 🇺🇸 United States

Primary endpoints

Change in PHQ-9 Score from Baseline to Day 30 Post-Last Infusion; Incidence of Safety Events During and After Ketamine Infusion

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: 15 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