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

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

Plain Language Summary

Simplified for easier understanding

This study compares ketamine infusion combined with psychotherapy sessions to ketamine infusion alone for treating moderate-to-severe depression, to find out whether the therapy component adds meaningful benefit. **You may be eligible if...** - You are aged 18–90 with a current diagnosis of major depressive disorder - Your depression is at least moderate in severity - You are in generally good physical health - You may remain on your current antidepressant medications at a stable dose **You may NOT be eligible if...** - You have a history of schizophrenia, bipolar disorder, or psychosis - You have a substance use disorder in the past 12 months - You have used ketamine recreationally in the past year or have not responded to ketamine before - You are pregnant, breastfeeding, or have significant heart or blood pressure issues - You have significant suicidal ideation or a recent suicide attempt - Your BMI is over 35 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT06559826


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