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NCT06559826 · ClinicalTrials.gov registry record · Phase 2
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
A Phase 2 study of Major Depressive Disorder, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06559826: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06559826 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 70 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06559826, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
MADRS: The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points, with higher scores indicating more severe depressive symptoms.
Conditions Studied
Interventions
- DRUG Ketamine
- BEHAVIORAL Psychotherapy
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2025-01-10 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
What NCT06559826 shows while recruiting
NCT06559826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT06559826 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06559826 about?
NCT06559826 is a clinical study titled "Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression". 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 depress...
What is the current status of trial NCT06559826?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2025-01-10. Estimated completion is 2027-08.
What conditions does trial NCT06559826 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06559826?
The interventions under investigation include: Ketamine (DRUG), Psychotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06559826?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06559826 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06559826's enrollment target sits among peer trials
70 157th of 282 higher than 123 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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