ACTIVE_NOT_RECRUITING

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

Conditions

Major Depressive Disorder Ketamine Mindfulness-Based Cognitive Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-30

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05950711

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Locations (Sites)

Harding Hospital

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-30

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2022-03-30

Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

Ketamine
Mindfulness-Based Cognitive Therapy
Major depressive disorder

Additional Relevant MeSH Terms

Major Depressive Disorder