search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Combination use of MBCT and IV Ketamine
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Ketamine, Mindfulness-Based Cognitive Therapy, Major depressive disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Harding HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine-MBCT Intervention

Arm Description

One Arm: Combination of MBCT with a single ketamine infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in PHQ9 score
Response defined a ≥50% reduction in depressive symptoms on the PHQ9
Correlation between MADRS/PHQ9 score and Mystic experience scores
analysis of possible correlation between depression scales scores and mystic experience during the ketamine infusion

Full Information

First Posted
April 3, 2023
Last Updated
July 10, 2023
Sponsor
Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT05950711
Brief Title
Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study
Official Title
Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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. Both ketamine and MBCT are used for treatment of depression, however, the combination of ketamine and psychotherapy has been studied mostly for drug addiction. Despite its rapid onset and effectiveness for depression, ketamine is most effective in the short term. MBCT is a therapeutic approach that combines cognitive behavioral techniques (CBT) with mindfulness strategies in order to help individuals better understand and manage their thoughts and emotions that can both decrease and prevent the relapse of the symptoms of depression. The aim of this pilot study is to embed one infusion of ketamine in the MBCT treatment. Our hypothesis is that the initial positive effect of ketamine will help patients engage in the behavioral therapy, which itself provides cognitive/emotion control tools to prevent relapses of depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Ketamine, Mindfulness-Based Cognitive Therapy, Major depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open Label Feasibility Study of an Intervention Without a Control Group
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine-MBCT Intervention
Arm Type
Experimental
Arm Description
One Arm: Combination of MBCT with a single ketamine infusion
Intervention Type
Other
Intervention Name(s)
Combination use of MBCT and IV Ketamine
Intervention Description
Group with Major Depression who will receive a single dose of IV Ketamine embedded within a course of MBCT.
Primary Outcome Measure Information:
Title
Change in MADRS score
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in PHQ9 score
Description
Response defined a ≥50% reduction in depressive symptoms on the PHQ9
Time Frame
12 months
Title
Correlation between MADRS/PHQ9 score and Mystic experience scores
Description
analysis of possible correlation between depression scales scores and mystic experience during the ketamine infusion
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Subhdeep Virk, MD
Phone
614-293-3811
Email
virk.1@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Marie Duchemin, MD
Phone
614-293-5517
Email
Anne-Marie.Duchemin@osumc.edu
Facility Information:
Facility Name
Harding Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subhdeep Virk, MD
Phone
614-293-3811
Email
virk.1@osu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share our data with other researchers

Learn more about this trial

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

We'll reach out to this number within 24 hrs