Anxiety & Depression Association of America

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

Purpose

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

Condition

Depression

Eligibility

Eligible Ages: Between 18 Years and 64 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Open label	Open label, single arm study	Drug: Ketamine-assisted psychotherapy Ketamine-assisted psychotherapy delivered in a group format

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Juliana Zambrano, MD, MPH

Study Contact

Juliana Zambrano, MD
617-726-2000
JZAMBRANO2@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.