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

NCT06597695 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2024P002122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting

  (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.

  1 week post-intervention

• To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting.

  (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.

  1 week post-intervention

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.

  1 and 12 weeks post-intervention

Study Arms (1)

Open label

EXPERIMENTAL

Open label, single arm study

Drug: Ketamine-assisted psychotherapy

Interventions

Ketamine-assisted psychotherapy DRUG

Ketamine-assisted psychotherapy delivered in a group format

Open label

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juliana Zambrano, MD, MPH: lead

Study Sites (1)

Massachusetts General Hospital, Chelsea

Chelsea, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Juliana Zambrano, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Central Study Contacts

Juliana Zambrano, MD

CONTACT

617-726-2000; JZAMBRANO2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (1)