Combining ketamine with mindfulness therapy for treating depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the feasibility of using intravenous ketamine, a rapid-acting antidepressant, in conjunction with Mindfulness-Based Cognitive Therapy (MBCT) for treating major depressive disorder. The study hypothesizes that the immediate effects of ketamine will enhance patient engagement in MBCT, which is designed to help individuals manage their thoughts and emotions to reduce the risk of depression relapse. Participants will receive one infusion of ketamine as part of their MBCT treatment, which combines cognitive behavioral techniques with mindfulness strategies. The study focuses on adults aged 18-65 who have moderate to severe depressive symptoms and have not responded adequately to previous antidepressant treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Harding Hospital
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Subhdeep Virk, MD
• Email: virk.1@osu.edu
• Phone: 614-293-3811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.