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Active, not recruitingPhase 4

Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study

NCT05950711 · Ohio State University

Closed to entry
Status
Not accepting participants
Phase 4
Phase
21
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose of this study is to assess the feasibility of combining IV ketamine, a rapid acting antidepressant, with a course of Mindfulness-Based Cognitive Therapy (MBCT), for the initial and maintenance treatment of depression.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in MADRS score

    Measured over 12 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Adults age 18-65 * A current diagnosis of major depressive disorder according to DSM-5 criteria per MINI interview * Moderate to severe level of current depressive symptoms (MADRS score ≥20) * Failure of at least one adequate trial of antidepressant medication (defined as: therapeutic doses of antidepressant medication for ≥ 6 weeks) * No adverse reactions to ketamine * Capacity to consent and comply with study procedures, including sufficient proficiency in English Exclusion Criteria: * Meets DSM-5 criteria for bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, active PTSD, dissociative disorders and current substance-induced mood disorder, OCD, eating disorder, panic disorder. * Suicide attempt in the past 4 weeks or current risk of suicide * Current alcohol or drug substance use disorder according to DSM-5 * Cognitive- or intellectual impairments which would interfere with participation in MBCT or assessments including meeting criteria for Delirium, Dementia, Amnesia, Cognitive Disorders, * Personality Disorders (borderline, antisocial, paranoid, schizoid, histrionic) that may interfere with treatment * Previous participation in MBCT or MBSR group * Pregnant or planning to become pregnant during the study period * Heart disease as indicated by history, abnormal ECG, previous cardiac surgery. * Hypertension (\>160/100) * Unstable physical disorders which might make participation hazardous such as history of AIDS, known lab abnormalities, active hepatitis or other liver disease with elevated transaminase levels (\< 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creatinine \> 2, BUN \>40), or untreated diabetes. * Previous history of ketamine misuse or abuse, or a history of an adverse reaction/experience with prior exposure to ketamine * BMI \> 32 * History of documented obstructive sleep apnea * On psychotropic or other medications whose effect could be disrupted by participation in the study or not allowed during the study (such as monoamine oxidase inhibitors). * Patient unable or unlikely to comply with the study protocol or for any other conditions that might indicate that the patient is unsuitable for the study as judged by the investigator * Positive urine drug screen, except for marijuana or benzodiazepine if prescribed.

Where

1 study site

FacilityCityRegionCountry
Harding HospitalColumbusOhioUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05950711 on ClinicalTrials.gov →

Last updated in the registry 2025-08-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits