Ketamine-assisted group therapy for Spanish-speaking adults with depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 pilot tests a ketamine-assisted group psychotherapy program delivered in Spanish to adults with major depressive disorder. The trial focuses on feasibility, safety, and preliminary signs of symptom improvement using standardized depression ratings (e.g., MADRS) and clinician evaluation. Eligible participants are self-identifying Latinx Spanish speakers aged 18–64 with a baseline MADRS score of 20 or higher and linked to an MGB psychiatrist and primary care provider. People with primary psychotic disorders, Bipolar I, severe recent substance use, uncontrolled cardiovascular issues, or certain neurocognitive or dissociative disorders are excluded for safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital, Chelsea
  Chelsea, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Juliana Zambrano, MD
• Email: JZAMBRANO2@mgh.harvard.edu
• Phone: 617-726-2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.