No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Other
Participants needed
10 (estimated)
Sponsor
Juliana Zambrano, MD, MPH · Other
Who this trial is looking for
This trial is looking for Spanish-speaking adults aged 18 to 64 with depression. Participants will receive group therapy that includes ketamine to see how well it works and how safe it is.
Are You a Good Fit for This Trial?
You may be able to join if
I speak Spanish.
I am between 18 and 64 years old.
I have been diagnosed with major depressive disorder.
My depression score is 20 or higher.
I have a psychiatrist and a primary care provider.
You may not be able to join if
I have a history of primary psychotic disorder.
I have a history of Bipolar I disorder.
I have unstable complex PTSD.
I have a history of dissociative identity disorder.
I have uncontrolled hypertension or unstable heart disease.
I have had severe substance use issues recently.
I weigh less than 18.5 or more than 35 according to BMI.
I am pregnant, breastfeeding, or planning to become pregnant soon.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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Eligibility 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-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist a…
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-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider.
Exclusion Criteria:
1. History of primary psychotic disorder, by history
2. History Bipolar I disorder, by history
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 after clinical evaluation and interview
7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. 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.
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