NCT06559826 Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
| NCT ID | NCT06559826 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2025-01-10 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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 Exclusion Criteria * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * 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 * Clinically significant abnormalities of laboratories, physical examination, or ECG * Substance drug or alcohol use disorder in the prior 12 months * 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 * Recreational ketamine or phencyclidine use in the last year * Previous non-response to clinical or research ketamine or esketamine administration * Concurrent treatment with ECT, TMS, or VNS in the current MDE * BMI \> 35 * Significant suicidal ideation as determined by a C-SSRS score \>2 in past 30 days * History of suicide attempt or self harm in the prior 2 years * SBP \> 165 or DBP \> 95 on infusion day * MoCA score \< 23
Contact & Investigator
James Murrough, MD, PhD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06559826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06559826 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06559826 currently recruiting?
Yes, NCT06559826 is actively recruiting participants. Contact the research team at rachel.fremont@mssm.edu for enrollment information.
Where is the NCT06559826 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06559826 clinical trial?
NCT06559826 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is James Murrough, MD, PhD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 70 participants.