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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2026-07-01

Brief Summary

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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

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Open label

Open label, single arm study

Group Type EXPERIMENTAL

Ketamine-assisted psychotherapy

Intervention Type DRUG

Ketamine-assisted psychotherapy delivered in a group format

Interventions

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Ketamine-assisted psychotherapy

Ketamine-assisted psychotherapy delivered in a group format

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No