Ketamine-assisted group therapy for Spanish-speaking adults with depression

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

This pilot will try ketamine-assisted group therapy to see if it helps Spanish-speaking adults with depression feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Chelsea, Massachusetts)
• Trial ID: NCT06597695 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 pilot tests a ketamine-assisted group psychotherapy program delivered in Spanish to adults with major depressive disorder. The trial focuses on feasibility, safety, and preliminary signs of symptom improvement using standardized depression ratings (e.g., MADRS) and clinician evaluation. Eligible participants are self-identifying Latinx Spanish speakers aged 18–64 with a baseline MADRS score of 20 or higher and linked to an MGB psychiatrist and primary care provider. People with primary psychotic disorders, Bipolar I, severe recent substance use, uncontrolled cardiovascular issues, or certain neurocognitive or dissociative disorders are excluded for safety.

Who should consider this trial

Good fit: Ideal candidates are self-identifying Latinx, Spanish-speaking adults aged 18–64 who meet DSM-5 criteria for major depressive disorder, have a MADRS score ≥20, and have an MGB psychiatrist and primary care provider.

Not a fit: Patients with a history of primary psychotic disorder, Bipolar I, uncontrolled cardiovascular disease, severe recent substance use disorder, dissociative identity disorder, or significant neurocognitive impairment are unlikely to benefit and are excluded for safety reasons.

Why it matters

Potential benefit: If successful, this could offer a culturally and linguistically tailored treatment option that reduces depressive symptoms for Spanish-speaking adults.

How similar studies have performed: Intravenous and other forms of ketamine have shown rapid antidepressant effects in multiple trials, but ketamine-assisted group psychotherapy—especially tailored for Spanish-speaking populations—is relatively novel with limited prior data.

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.

Where this trial is running

Chelsea, Massachusetts

• Massachusetts General Hospital, Chelsea — Chelsea, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Juliana Zambrano, MD

Conditions: Depression