Actively Recruiting
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-15
70
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The proposed study is a single-site, randomized, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study participants will be adults with major depressive disorder (MDD). Adults with MDD will be randomized to KAP or KET in a 1:1 allocation. Each treatment group will receive KAP or KET over a period of four weeks. Measurement of depression severity, wellness, neurocognitive functioning and other parameters will occur at baseline prior to treatment, immediately following the end of the acute treatment period, and over an 8-week (two month) treatment follow-up period.
CONDITIONS
Official Title
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and can comply with study requirements
- Aged between 18 and 90 years
- In good physical health
- On stable medication doses for depression if applicable
- Scored at least 20 on the 10-item Montgomery-Asberg Depression Scale at screening indicating moderate or higher depression
- Diagnosed with major depressive disorder currently in a major depressive episode according to DSM-5
- For women of child-bearing potential, have a negative pregnancy test at screening and before ketamine infusion
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to use birth control during the study
- Any condition or abnormality that might affect safety or data quality as judged by the investigator
- Unstable medical illnesses including liver, kidney, gastrointestinal, respiratory, heart, endocrine, neurological, immune, or blood disorders
- Clinically significant abnormalities in labs, physical exams, or ECG
- Substance or alcohol use disorder within the last 12 months
- History of allergy to ketamine or esketamine
- Lifetime history of schizophrenia, schizoaffective disorder, or bipolar I or II disorder
- Psychotic symptoms currently or any lifetime psychotic disorder
- Recreational ketamine or phencyclidine use in the last year
- Previous lack of response to ketamine or esketamine treatment
- Concurrent treatment with ECT, TMS, or VNS for current depressive episode
- Body mass index (BMI) over 35
- Significant suicidal thoughts or behavior recently or suicide attempt/self-harm in the past 2 years
- Blood pressure above specified limits on infusion day
- Montreal Cognitive Assessment (MoCA) score below 23
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
R
Rachel Fremont, MD, PhD
CONTACT
M
Mackenzie Brown, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here