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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950711
• Other study ID #: 2020H0374
• Status: Recruiting
• Phase: Phase 4
• Start date: March 30, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: Ohio State University
• Contact: Subhdeep Virk, MD
• Phone: 614-293-3811
• Email: virk.1[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Combination use of MBCT and IV Ketamine
Group with Major Depression who will receive a single dose of IV Ketamine embedded within a course of MBCT.

Locations

Country	Name	City	State
United States	Harding Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in PHQ9 score	Response defined a =50% reduction in depressive symptoms on the PHQ9	12 months
Secondary	Correlation between MADRS/PHQ9 score and Mystic experience scores	analysis of possible correlation between depression scales scores and mystic experience during the ketamine infusion	12 months