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

Last updated: July 23, 2025
Sponsor: Juliana Zambrano, MD, MPH
Overall Status: Active - Recruiting

Phase

1/2

Condition

Depression

Treatment

Ketamine-assisted psychotherapy

Clinical Study ID

NCT06597695
2024P002122
  • Ages 18-64
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  1. Self-identifying Latinx, Spanish-speaking 2. Adults 18-64 years 3. Meet DSM-5criteria 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

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 assessedby study clinician after clinical evaluation and interview

  7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, byhistory 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 oftreatment completion

  17. Enrolled in other clinical trial for the treatment of depression or other behavioralhealth diagnosis

  18. Inability to provide consent.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Ketamine-assisted psychotherapy
Phase: 1/2
Study Start date:
July 23, 2025
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • Massachusetts General Hospital, Chelsea

    Chelsea, Massachusetts 02114
    United States

    Active - Recruiting

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