Ketamine-Assisted Psychotherapy for Depression
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
Recruiting
Phase 2
Interventional Study
Major Depressive Disorder
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.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Other
Who this trial is looking for
This trial is looking for adults with major depressive disorder who want to try a new treatment. Participants will receive either ketamine with therapy or ketamine alone over four weeks and attend follow-up appointments.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 90 years old.
- I have been diagnosed with major depressive disorder.
- I am in good physical health.
- I can provide written consent to join the study.
- I have a depression score of at least 20.
- I am not currently pregnant, and if I can become pregnant, I have a negative pregnancy test.
- I am on stable medication for depression.
You may not be able to join if
- I am pregnant or breastfeeding.
- I have had any unstable medical illnesses recently.
- I have a history of substance abuse in the past 12 months.
- I have a lifetime history of schizophrenia or bipolar disorder.
- I have significant suicidal thoughts.
- I have had a suicide attempt in the last 2 years.
- I have had hypersensitivity to ketamine.
- I have a BMI greater than 35.
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.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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 treat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria
* Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.
* Age 18-90 years
* Participant in good physical health
* Participants may be on medications for depression as long as they remain o…
Contacts