RecruitingPhase 1Phase 2NCT06597695
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
Sponsor
Juliana Zambrano, MD, MPH
Enrollment
10 participants
Start Date
Jul 23, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 64 Years
Plain Language Summary
Simplified for easier understanding
This study is testing ketamine-assisted group therapy for Spanish-speaking Latino adults with depression who have not responded well to standard treatments. Ketamine is an anesthetic agent that has shown rapid antidepressant effects and is being studied in combination with group psychotherapy.
**You may be eligible if...**
- You identify as Latinx and speak Spanish
- You are between 18 and 64 years old
- You have been diagnosed with major depressive disorder
- You have significant depression symptoms (MADRS score of 20 or above)
- You have both an MGB psychiatrist and a primary care provider
**You may NOT be eligible if...**
- You have a history of schizophrenia, bipolar I disorder, dissociative identity disorder, or neurocognitive disorder
- You have unstable complex PTSD
- You have a severe or recent substance use disorder
- You have uncontrolled high blood pressure or heart disease
- You have a history of heart attack, aneurysm, aortic dissection, liver disease, or epilepsy
- Your BMI is below 18.5 or above 35
- You are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of finishing treatment
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGKetamine-assisted psychotherapy
Ketamine-assisted psychotherapy delivered in a group format
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06597695
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