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Ketamine-Assisted Psychotherapy for Depression

This study is comparing two approaches for treating Major Depressive Disorder (MDD): ketamine-assisted psychotherapy (KAP) and ketamine alone. You could be eligible if you are an adult between 18 and 90 years old, in good physical health, and potentially already taking stable depression medication. The study aims to see if KAP is more effective than ketamine alone by measuring changes in depression severity using a scale called the Montgomery-Asberg Depression Rating Scale (MADRS) after 9 weeks. The study plans to enroll 70 participants, but its current status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to receive either ketamine-assisted psychotherapy or ketamine alone. It is a single-site study.
What's involved
Participants will receive treatment over four weeks, which includes four to five ketamine sessions. Those in the KAP group will also have preparatory and weekly integration sessions.
Compensation
Not stated in the trial record.
Follow-up
Your depression severity and other measures will be tracked for an 8-week (two-month) period after the main treatment ends.

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NCT06559826

Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression

Recruiting
PHASE2Ages 18–90InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~70 participants
Updated 2025-07-15 on ClinicalTrials.gov
What's tested:KetaminePsychotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured over 9 weeks from baseline assessment

Conditions

Major Depressive Disorder

Explore related trials

Unipolar Depression

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • James Murrough, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Rachel Fremont, MD, PhD
[email protected]
212-241-6539
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Montgomery-Asberg Depression Rating Scale (MADRS)9 weeks from baseline assessment

    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.