Recruiting
Phase 1
Phase 2

Ketamine

Sponsor:

Juliana Zambrano, MD, MPH

Code:

NCT06597695

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Ketamine-assisted psychotherapy

Study Details

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

Conditions

Depression

Study ID

NCT06597695

Start date

Jul 23, 2025

Status verified date

Jul, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Open label

Open label, single arm study

Interventions

Ketamine-assisted psychotherapy

Ketamine-assisted psychotherapy delivered in a group format

Primary outcome measure

  • Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting [ Time Frame: 1 week post-intervention ]
  • To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting. [ Time Frame: 1 week post-intervention ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital, Chelsea

Recruiting

Chelsea, Massachusetts, United States, 02114

Contacts

Juliana zambrano, MD, MPH

6177262000jzambrano2@mgh.harvard.edu

More Information

Sponsor

Juliana Zambrano, MD, MPH

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Juliana Zambrano, MD, MPH on 2025-07-28.