Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression

This study is looking at how ketamine affects the brain in people with depression that hasn't improved with other treatments (treatment-resistant depression, or TRD). TRD can be very difficult, and there's a strong need for fast-acting treatments. Ketamine has shown promise as a rapid antidepressant and can lead to experiences that might improve mental health. In this study, you would receive 0.5-1mg/kg of ketamine hydrochloride by injection into a muscle, along with psychotherapy sessions. Researchers will measure how many people stay in the study for two months and track changes in their depression symptoms using a scale called the Hamilton Depression Rating Scale (HDRS). You could join if you are 18 or older, speak English, are generally healthy, and have TRD.

Study design
This is a single-center study with 25 planned participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would have 2 brain scanning visits and 6 visits to the Department of Psychiatry. You would also receive 1-2 ketamine injections and 3-4 psychotherapy sessions.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two months after enrolling in the study.

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NCT07247006

Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Rochester
~25 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Ketamine hydrochloride injection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Retained in Study Through 2-Month Follow-Up
Measured over 2 months post-enrollment
+1 more outcome measured
Treatment Resistant Depression (TRD)
Chronic Pain
1 sites across 1 states
New York1

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  • Proportion of Participants Retained in Study Through 2-Month Follow-Up2 months post-enrollment

    Retention will be assessed as completion of all scheduled study assessments through the 2-month follow-up. A single value is derived for each participant, coded as 1 (retained) or 0 (not retained). Higher values indicate successful retention; lower values indicate dropout.

  • Mean Change in Hamilton Depression Rating Scale (HDRS) Total ScoreBaseline, once a day for up to 7 days after baseline, within 90 minutes after ketamine dosing session, once a day for up to 7 days after ketamine dosing session, once a day up to 7 days before 2-month follow-up, and at 2-month follow-up

    Depression severity will be measured using the 17-item HDRS (items scored 0-2 or 0-4; total score range 0-52). A single value is derived by summing item scores. Higher scores indicate greater depression severity (worsening); lower scores indicate reduced severity (improvement). Mean change is calculated as post-treatment score minus baseline score.