A Ketamine-assisted Group Therapy Intervention... — Clinical Trial Details

Pilot single-arm, open-label study (n=10) assessing feasibility, safety, and preliminary efficacy of ketamine-assisted group psychotherapy for Spanish-speaking adults with major depressive disorder (MADRS ≥20).

Intervention delivered in a group format; single-group design with estimated enrollment of 10. Primary aims are feasibility and safety with exploratory clinical outcome assessment.

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–Åsberg Depression Rating Scale (MADRS) score of 20 or above at baseline
5. Participants must have an MGB psychiatrist and primary care provider.

Exclusion Criteria:
1. History of primary psychotic disorder
2. History of Bipolar I disorder
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
7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease (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.

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

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Open label

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Inclusion Criteria

Exclusion Criteria

Study Details