Status:
RECRUITING
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
Lead Sponsor:
Juliana Zambrano, MD, MPH
Conditions:
Depression
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06597695
Start Date
July 23 2025
End Date
July 1 2026
Last Update
July 28 2025
Active Locations (1)
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1
Massachusetts General Hospital, Chelsea
Chelsea, Massachusetts, United States, 02114