Recruiting

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

What is being tested

Ketamine-assisted psychotherapy

Drug

Who is being recruted

Behavior

+ Behavioral Symptoms

+ Depression

From 18 to 64 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Phase 1 & 2

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorJuliana Zambrano, MD, MPH

Study ContactJuliana Zambrano, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 23, 2025

Actual date on which the first participant was enrolled.

This study focuses on exploring a new treatment method for Spanish-speaking adults who experience depression. The research is investigating whether combining ketamine, a medication known for its potential effects on mood, with group therapy can be a safe and effective approach. Depression is a challenging condition that affects many individuals, and finding suitable treatments for Spanish-speaking communities is essential. The aim is to understand if this combined method could offer better support and outcomes for those struggling with depression. Participants in the study will undergo ketamine-assisted group therapy sessions. Ketamine will be administered under controlled conditions, and the effects will be monitored during group therapy sessions. Researchers will assess the feasibility of this approach, ensuring it is safe and observing any changes in depressive symptoms. The study does not specify particular risks or benefits, as it is in an early phase, but it aims to gather preliminary data on how this treatment impacts participants' mental health.

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

NCT06597695

Principal SponsorJuliana Zambrano, MD, MPH

Study ContactJuliana Zambrano, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsDepression

Criteria

1 inclusion criteria required to participate

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-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider.

18 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Open label, single arm study

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Massachusetts General Hospital, Chelsea

Chelsea, United StatesOpen Massachusetts General Hospital, Chelsea in Google Maps

Recruiting

One Study Center