A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 64 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This small study tests ketamine-assisted group therapy for Spanish-speaking Latinx adults ages 18–64 with depression. It looks at whether the treatment is practical, safe, and may help with depression.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Identify as Latinx and speak Spanish.
- Be 18–64 years old.
- Have major depression, as diagnosed by a study clinician using standard guidelines.
- Score at least 20 on the MADRS, a scale that measures depression symptoms, at the start of the study.
- Have both a psychiatrist and a primary care provider at MGB.
Who can't join
- Have a history of a psychotic disorder (trouble knowing what is real), bipolar I disorder (extreme mood changes), dissociative identity disorder (separate identities), or a disorder affecting memory and thinking; or have unstable complex PTSD (ongoing symptoms after trauma).
- Have a history of severe or recent problems with alcohol or drug use, as judged by the study clinician.
- Have uncontrolled high blood pressure, a fast heartbeat, or unstable heart or lung disease; or a history of heart attack, a tear in the body's main artery, or an aneurysm (a bulging blood vessel). Blood pressure at screening must be below 140/90.
- Have a history of liver problems, epilepsy (a seizure disorder), or an allergic reaction to ketamine.
- Have a body mass index (BMI, a measure based on height and weight) above 35 or below 18.5.
- Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks after treatment ends.
- Are in another clinical trial treating depression or another mental or behavioral health condition.
- Cannot give consent to take part.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. Exclusion Criteria: 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.
Study sites (1)
MA
- Massachusetts General Hospital, Chelsea · Chelsea, MA 02114Juliana zambrano, MD, MPH · Study contact · 6177262000 · jzambrano2@mgh.harvard.eduMore trials in Chelsea