Status:
RECRUITING
Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 medi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06559826
Start Date
January 10 2025
End Date
August 1 2027
Last Update
July 15 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029