NCT06597695 · Juliana Zambrano, MD, MPH
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
What this study is about
This is a pilot clinical trial to assess the feasibility, safety, and preliminary effectiveness of ketamine-assisted group therapy for Spanish-speaking adults with depression
View original scientific 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Chelsea, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2025 · Source of record for eligibility and locations