Comparing ketamine-assisted psychotherapy to ketamine alone for treating depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized controlled trial that aims to compare the effectiveness of ketamine-assisted psychotherapy (KAP) with standard ketamine treatment without psychotherapy (KET) in adults suffering from major depressive disorder (MDD). Participants will be randomly assigned to either KAP or KET and will undergo treatment over a four-week period. The study will assess various outcomes, including depression severity and neurocognitive functioning, at baseline, immediately after treatment, and during an eight-week follow-up. The goal is to determine if the addition of psychotherapy enhances the therapeutic effects of ketamine.

Why it matters

Who can join: the full rules

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 \> less than or equal to 40.
* 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

Where it's running

• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: James Murrough, MD, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Rachel Fremont, MD, PhD
• Email: rachel.fremont@mssm.edu
• Phone: 212-241-6539

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.