NCT06559826RecruitingPhase 2
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 15 Aug 2024
- Start date
- 10 Jan 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Depression
- NCT number
- NCT06559826
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 10 Jan 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Substance drug or alcohol use disorder in the prior 12 months
- Previous non-response to clinical or research ketamine or esketamine administration
- Concurrent treatment with ECT, TMS, or VNS in the current MDE
- History of suicide attempt or self harm in the prior 2 years
Other illness
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease
- History of hypersensitivity to ketamine or esketamine
- Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder
- Presence of psychotic symptoms in the current MDE, or lifetime psychotic disorder
Other
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Clinically significant abnormalities of laboratories, physical examination, or ECG
- Recreational ketamine or phencyclidine use in the last year
- BMI \> less than or equal to 40.
- Significant suicidal ideation as determined by a C-SSRS score \>2 in past 30 days
- SBP \> 165 or DBP \> 95 on infusion day
- MoCA score \< 23
Who the study is looking for
- 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 on a stable dose.
- A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity.
- Meets criteria for major depressive disorder (MDD) in current major depressive episode (MDE) according to DSM-5
- Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.