Ketamine-Assisted Mindfulness-Based Cognitive... — Clinical Trial Details

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.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

0 - 32

Psychosis History

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.

Company

Product

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Ketamine + MBCT

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators