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A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression

A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression

Recruiting
18-64 years
All
Phase 1/2

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Overview

This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression

Eligibility

Inclusion Criteria:

  1. Self-identifying Latinx, Spanish-speaking 2. Adults 18-64 years 3. Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician 4. Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider.

Exclusion Criteria:

  1. History of primary psychotic disorder, by history
  2. History Bipolar I disorder, by history
  3. Unstable complex PTSD, as assessed by study clinician
  4. History of dissociative identity disorder
  5. History of neurocognitive disorder
  6. History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview
  7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be <140/90 mmHg.
  8. History of aortic dissection
  9. History of myocardial infarction
  10. History of aneurysm
  11. History of hepatic impairment.
  12. History of epilepsy
  13. History of prior hypersensitivity to ketamine
  14. Body Mass Index greater than 35
  15. Body Mass Index less than 18.5
  16. Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion
  17. Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis
  18. Inability to provide consent.

Study details
    Depression

NCT06597695

Juliana Zambrano, MD, MPH

16 October 2025

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