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

NCT05950711 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 2020H0374
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Ketamine; Mindfulness-Based Cognitive Therapy; Major depressive disorder

Outcome Measures

Primary Outcomes (1)

• Change in MADRS score

  Response defined a ≥50% reduction in depressive symptoms as measured of standardized measures; remission defined as decrease of depression scores below cut-off for the scale

  12 months

Secondary Outcomes (2)

• Change in PHQ9 score

  12 months

• Correlation between MADRS/PHQ9 score and Mystic experience scores

  12 months

Study Arms (1)

Ketamine-MBCT Intervention

EXPERIMENTAL

One Arm: Combination of MBCT with a single ketamine infusion

Other: Combination use of MBCT and IV Ketamine

Interventions

Combination use of MBCT and IV Ketamine OTHER

Group with Major Depression who will receive a single dose of IV Ketamine embedded within a course of MBCT.

Ketamine-MBCT Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Harding Hospital

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Feasibility Study of an Intervention Without a Control Group

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: July 18, 2023
• Study Start: March 30, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)