RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07-23

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06597695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Juliana Zambrano, MD

CONTACT

617-726-2000

JZAMBRANO2@mgh.harvard.edu

Principal Investigator

Juliana Zambrano, MD

STUDY_DIRECTOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital, Chelsea

Chelsea, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Juliana Zambrano, MD, MPH

Juliana Zambrano, MD, STUDY_DIRECTOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-23

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2025-07-23

Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

Depression