Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a ketamine-assisted group therapy for Spanish-speaking adults aged 18 to 64 with depression. This pilot clinical trial aims to assess whether this culturally adapted group intervention is feasible and safe in a community setting while also exploring its preliminary effects on psychiatric symptoms, wellbeing, and health behaviors. Participants must meet criteria for major depressive disorder and have moderate to severe symptoms based on a depression scale. The study involves an open-label, single-arm design where all participants receive ketamine-assisted psychotherapy delivered in a group format. The treatment is tailored specifically for Spanish-speaking adults and is provided under medical supervision. There is no placebo or comparison group in this phase 1 and 2 study. Participants will be observed and evaluated over several weeks, with key assessments occurring one week after treatment to measure feasibility and safety, and follow-up evaluations at one and twelve weeks post-intervention to examine changes in depression symptoms and overall health. Safety monitoring includes clinical evaluation by a psychiatrist and assessments related to medical history and vital signs. The total participation period extends through these follow-up visits to collect comprehensive data on the intervention's impact.
CONDITIONS
Brief Title
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identifying Latinx, Spanish-speaking
- Adults aged 18 to 64 years
- Diagnosis of major depressive disorder according to DSM-5 criteria
- Montgomery-Asberg Depression Rating Scale score of 20 or above at baseline
- Must have both a psychiatrist and a primary care provider
You will not qualify if you...
- History of primary psychotic disorder
- History of Bipolar I disorder
- Unstable complex PTSD
- History of dissociative identity disorder
- History of neurocognitive disorder
- History of severe or recent substance use disorder
- Uncontrolled hypertension or tachycardia, unstable cardiopulmonary disease, or blood pressure above 140/90 mmHg at screening
- History of aortic dissection, myocardial infarction, aneurysm, hepatic impairment, or epilepsy
- Prior hypersensitivity to ketamine
- Body Mass Index less than 18.5 or greater than 35
- Pregnant, breastfeeding, or planning pregnancy within 12 weeks of treatment completion
- Currently enrolled in another clinical trial for depression or behavioral health
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the group therapy intervention as per protocol
Participants receive ketamine-assisted psychotherapy delivered in a group format.
Group therapy sessions according to study schedule
Duration - Up to 12 weeks post-intervention
Participants are monitored for safety and efficacy outcomes after completing the ketamine-assisted group therapy intervention.
Visits at 1 week and 12 weeks post-intervention
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital, Chelsea
Chelsea, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Juliana Zambrano, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here