Clinical TrialMajor Depressive Disorder (MDD)KetamineRecruiting

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

This open-label, early Phase I trial (n=10) will assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression.

Target Enrollment
10 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Open label

experimental

Open-label, single-arm group ketamine-assisted psychotherapy

Interventions

  • Ketamine

    Group-format ketamine-assisted psychotherapy; dose and route per protocol

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion 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–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

  • 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.

Study Details

  • Status
    Recruiting
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2025-01-01
    End: 2025-07-01
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

Locations

Massachusetts General Hospital, Chelsea — Chelsea, Massachusetts, United States

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