Clinical TrialMajor Depressive Disorder (MDD)KetamineActive not recruiting

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

This open-label feasibility study (n=21) will assess the combination of IV ketamine with Mindfulness-Based Cognitive Therapy (MBCT) for the treatment of depression.

Target Enrollment
21 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Open-label, single-group pilot embedding a single IV ketamine infusion within a course of Mindfulness-Based Cognitive Therapy for adults with major depressive disorder (MADRS ≥20).

Primary aim is feasibility: whether the rapid antidepressant effect of ketamine facilitates engagement with MBCT and whether combined treatment is acceptable and safe; outcomes include depressive symptoms, tolerability, and retention.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

mindfulnesscbt

Study Arms & Interventions

Ketamine + MBCT

experimental

Single-group MBCT course with a single IV ketamine infusion embedded in treatment.

Interventions

  • Ketamine
    via IV• single dose

    Single IV ketamine infusion embedded within MBCT (dose per protocol).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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.

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment21 participants
  • Timeline
    Start: 2022-03-30
    End: 2023-11-30
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

Locations

Harding Hospital — Columbus, Ohio, United States

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