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RecruitingPhase 1 / Phase 2

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

NCT06597695 · Juliana Zambrano, MD, MPH

Recruiting
Status
Accepting participants
Phase 1 / Phase 2
Phase
10
Target enrolment
1
Study sites
1 US states

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting

    Measured over 1 week post-intervention

  • To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting.

    Measured over 1 week post-intervention

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Massachusetts General Hospital, ChelseaChelseaMassachusettsUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06597695 on ClinicalTrials.gov →

Last updated in the registry 2025-07-28. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication

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