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
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
Connect with a study center
Harding Hospital
Columbus, Ohio 43210
United StatesActive - Recruiting
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