RecruitingPhase 1Phase 2NCT06597695
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
Sponsor
Juliana Zambrano, MD, MPH
Enrollment
10 participants
Start Date
Jul 23, 2025
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 YearsMax Age: 64 Years
Inclusion Criteria1
- \. 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 Criteria18
- 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.
Interventions
DRUGKetamine-assisted psychotherapy
Ketamine-assisted psychotherapy delivered in a group format
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06597695
Related Trials
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
NCT0679339767 locations
Acute Psychiatric Care at Home for Lower-risk Patients With Acute Psychiatric Illness Who Require Inpatient Care
NCT073648253 locations
Cerebellar Stimulation and Cognitive Control
NCT032171101 location
The Effects of High-dose Vitamin B6 on Depression and Anxiety Symptoms
NCT074694621 location
CAPABLE Transplant
NCT063269051 location