RecruitingPhase 2NCT06559826

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

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

70 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria7

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 Criteria16

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

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Interventions

DRUGKetamine

Following screening and baseline assessments, individuals randomized to KAP will undergo a preparatory session prior to the first day of dosing. Participants will complete a sequence of four to five intramuscular (IM) ketamine assisted therapy sessions.

BEHAVIORALPsychotherapy

Each week following KAP, there will be a separate 60-minute integration session 1-6 days afterwards. Integration sessions will focus on processing experiences and material that emerged in KAP sessions (such as assimilating challenging experiences, making meaning of experiences and imagery, working through memories and emotions, and exploring emerging relational patterns) as well as strengthening insights. Within one week of the completion of all KAP sessions, there will be one additional integration session focused on consolidating the insights and improvements gained from KAP treatment.