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NCT Number: NCT06597695

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

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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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital, Chelsea

Chelsea, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Juliana zambrano, MD, MPH

CONTACT

[email protected]

6177262000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • History of primary psychotic disorder, by history
  • History Bipolar I disorder, by history
  • Unstable complex PTSD, as assessed by study clinician
  • History of dissociative identity disorder
  • History of neurocognitive disorder
  • History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview
  • Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be <140/90 mmHg.
  • History of aortic dissection
  • History of myocardial infarction
  • History of aneurysm
  • History of hepatic impairment.
  • History of epilepsy
  • History of prior hypersensitivity to ketamine
  • Body Mass Index greater than 35
  • Body Mass Index less than 18.5
  • Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion
  • Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis
  • Inability to provide consent.

Treatment and study plan

Ketamine-assisted psychotherapy

Drug

Ketamine-assisted psychotherapy delivered in a group format

Primary outcomes

  1. 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

    (a) Assess the attendance and adherence rates of participants to the group-based ketamine intervention sessions; (b) Evaluate the feasibility of delivering the intervention sessions as planned, including the preparatory, dosing, and integration sessions; (c) Explore the perceptions and experiences of Spanish-speaking participants regarding the intervention.

  2. 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

    (a) assess safety as obtained through vital monitoring; heart-rate variability (HRV) monitoring, EKG, as measured by a Fitbit. (b) evaluate physical and psychological adverse effects at each study visit.

Secondary outcomes

  1. Investigate the preliminary efficacy of the group-based ketamine intervention on psychiatric symptoms, wellbeing, and health behaviors among Spanish-speaking participants with depression.

    Time frame: 1 and 12 weeks post-intervention

    (a) Assess changes in psychiatric symptom scales pre- and post-intervention using validated assessment tools. (b) Measure changes in wellbeing (social wellbeing, personal wellbeing, spiritual health) pre- and post- intervention through self-report scales. Explore shifts in health behaviors pre-and post-intervention, through self-report and accelerometry measures.

Study contacts

Contact information is provided by the study sponsor or research team.

Juliana Zambrano, MD

CONTACT

[email protected]

617-726-2000

Sponsors and collaborators

Lead sponsor

Juliana Zambrano, MD, MPH

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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