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

Last updated: July 10, 2023
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

4

Condition

Depression

Affective Disorders

Depression (Major/severe)

Treatment

Combination use of MBCT and IV Ketamine

Clinical Study ID

NCT05950711
2020H0374
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults age 18-65
  • A current diagnosis of major depressive disorder according to DSM-5 criteria per MINIinterview
  • 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 proficiencyin English

Exclusion

Exclusion Criteria:

  • Meets DSM-5 criteria for bipolar disorder, schizophrenia, any psychotic illness,including substance-induced psychosis, active PTSD, dissociative disorders and currentsubstance-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 inMBCT or assessments including meeting criteria for Delirium, Dementia, Amnesia,Cognitive Disorders,
  • Personality Disorders (borderline, antisocial, paranoid, schizoid, histrionic) thatmay 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 historyof AIDS, known lab abnormalities, active hepatitis or other liver disease withelevated transaminase levels (< 2-3 X upper limit of normal will be consideredacceptable if PT/PTT is normal), renal failure (creatinine > 2, BUN >40), or untreateddiabetes.
  • Previous history of ketamine misuse or abuse, or a history of an adversereaction/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 participationin 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 otherconditions that might indicate that the patient is unsuitable for the study as judgedby the investigator
  • Positive urine drug screen, except for marijuana or benzodiazepine if prescribed.

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Combination use of MBCT and IV Ketamine
Phase: 4
Study Start date:
March 30, 2022
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • Harding Hospital

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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