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

Mass General Brigham

Status and phase: Begins enrollment in 3 months; Early Phase 1

Conditions: Depression

Treatments: Drug: Ketamine-assisted psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06597695

2024P002122

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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. 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Open label

Experimental group

Description:

Open label, single arm study

Treatment:

Drug: Ketamine-assisted psychotherapy