Phase 2 Depression and Anxiety Trial, Recruiting NCT06597695 Sponsor: Juliana Zambrano, MD, MPH Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT06597695
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 who identify as Latinx and speak Spanish
  • Adults between 18 and 64 years old
  • People who have been assessed by a study clinician and meet the clinical diagnostic criteria for major depressive disorder
  • People whose depression symptom score on a standard rating scale (called the MADRS) is 20 or above at the start of the study
  • People who already have both a psychiatrist and a primary care doctor within the MGB (Mass General Brigham) health system

Who may not be able to join:

  • People with a history of a primary psychotic disorder
  • People with a history of Bipolar I disorder
  • People with unstable complex PTSD, as assessed by a study clinician
  • People with a history of dissociative identity disorder
  • People with a history of a neurocognitive disorder (such as dementia)
  • People with a history of severe or recent substance use disorder, as assessed by a study clinician
  • People with uncontrolled high blood pressure, a fast heart rate, or unstable heart or lung disease — blood pressure must be below 140/90 mmHg at the initial screening
  • People with a history of aortic dissection (a serious condition affecting the main artery from the heart)
  • People with a history of heart attack
  • People with a history of an aneurysm (a bulge in a blood vessel)
  • People with a history of liver impairment
  • People with a history of epilepsy
  • People with a history of a previous allergic reaction to ketamine
  • People with a Body Mass Index (BMI) greater than 35
  • People with a Body Mass Index (BMI) less than 18.5
  • People who are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of finishing treatment
  • People currently enrolled in another clinical trial for depression or another behavioural health condition
  • People who are unable to provide informed consent

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

Principal Investigator: Juliana Zambrano, MD, Massachusetts General Hospital

Phone: 617-726-2000

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
Juliana Zambrano, MD, MPH
Registry
ClinicalTrials.gov
Start date
23 July 2025
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting; To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting.

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