Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 64Years
All Genders
NCT06597695

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

Led by Juliana Zambrano, MD, MPH · Updated on 2025-07-28

10

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-identifying Latinx, Spanish-speaking
  • Adults aged 18 to 64 years
  • Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician
  • Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline
  • Must have an MGB psychiatrist and primary care provider
Not Eligible

You will not qualify if you...

  • History of primary psychotic disorder
  • History of Bipolar I disorder
  • Unstable complex PTSD as assessed by study clinician
  • History of dissociative identity disorder
  • History of neurocognitive disorder
  • History of severe or recent substance use disorder
  • Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease
  • Blood pressure on initial screen must be below 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
  • Pregnant, breastfeeding, or planning pregnancy within 12 weeks of treatment completion
  • Enrolled in other clinical trial for depression or behavioral health
  • Inability to provide consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital, Chelsea

Chelsea, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

J

Juliana Zambrano, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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