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

Recruiting now · Phase 1/Phase 2

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT06597695

Run by

Juliana Zambrano, MD, MPH

People needed

10

Starts

2025-07-23

Expected to finish

2026-07-01

Last updated by the study team

2025-07-28

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• History of primary psychotic disorder, by history
• History Bipolar I disorder, by history
• Unstable complex PTSD, as assessed by study clinician
• History of dissociative identity disorder
• History of neurocognitive disorder
• History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview
• Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be <140/90 mmHg.
• History of aortic dissection
• History of myocardial infarction
• History of aneurysm
• History of hepatic impairment.
• History of epilepsy
• History of prior hypersensitivity to ketamine
• Body Mass Index greater than 35
• Body Mass Index less than 18.5
• Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion
• Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis
• Inability to provide consent.

Where it is running

• Massachusetts General Hospital, Chelsea — Chelsea, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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