Major Depressive DisorderPhase 4NCT05950711
Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study
A Phase 4 study testing Combination use of MBCT and IV Ketamine in people with Major Depressive Disorder, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Combination use of MBCT and IV Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 30 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Combination use of MBCT and IV Ketamine
- Keywords
- Ketamine, Mindfulness-Based Cognitive Therapy, Major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination use of MBCT and IV KetamineOther
Group with Major Depression who will receive a single dose of IV Ketamine embedded within a course of MBCT.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine-MBCT Intervention | Experimental | One Arm: Combination of MBCT with a single ketamine infusion Receives: Other: Combination use of MBCT and IV Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS score
Response defined a ≥50% reduction in depressive symptoms as measured of standardized measures; remission defined as decrease of depression scores below cut-off for the scale
Measured: 12 months
Secondary outcomes (2)
Change in PHQ9 score
Response defined a ≥50% reduction in depressive symptoms on the PHQ9
Measured: 12 months
Correlation between MADRS/PHQ9 score and Mystic experience scores
analysis of possible correlation between depression scales scores and mystic experience during the ketamine infusion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start30 Mar 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Feasibility Study of an Intervention Without a Control Group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950711
- Sponsor's protocol ID
- 2020H0374
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share our data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT05950711
- Acronym / sponsor ID
- 2020H0374
- Conditions
- Major Depressive Disorder
- Keywords
- Ketamine, Mindfulness-Based Cognitive Therapy, Major depressive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label Feasibility Study of an Intervention Without a Control Group
| Arm | Type | Receives |
|---|---|---|
| Ketamine-MBCT Intervention | Experimental | Other: Combination use of MBCT and IV KetamineOne Arm: Combination of MBCT with a single ketamine infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination use of MBCT and IV KetamineGroup with Major Depression who will receive a single dose of IV Ketamine embedded within a course of MBCT. | Other | Ketamine-MBCT Intervention |
Primary outcome
Change in MADRS score
Time frame: 12 months
Response defined a ≥50% reduction in depressive symptoms as measured of standardized measures; remission defined as decrease of depression scores below cut-off for the scale
2 secondary outcomes
Change in PHQ9 score
Time frame: 12 months
Correlation between MADRS/PHQ9 score and Mystic experience scores
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No. There is no plan to share our data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination use of MBCT and IV Ketamine in people with Major Depressive Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MADRS score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.