RECRUITING

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

Description

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

Conditions

Study Overview

Study Details

Study 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

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

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

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

Chelsea

Massachusetts General Hospital, Chelsea, Chelsea, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Juliana Zambrano, MD, MPH,

Juliana Zambrano, MD, STUDY_DIRECTOR, Massachusetts General Hospital

Study Record Dates

2026-07-01