MBCT + IV Ketamine for Depression

Overseen By Anne-Marie Duchemin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ohio State University

Must be taking: Antidepressants

Must not be taking: MAO inhibitors

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for depression by combining IV ketamine, which quickly relieves symptoms, with Mindfulness-Based Cognitive Therapy (MBCT), a talk therapy focused on presence and awareness. The goal is to determine if this combination can effectively reduce depression symptoms and maintain improvements over time. The trial seeks participants diagnosed with major depressive disorder who have moderate to severe symptoms and have not found relief from at least one antidepressant medication. Participants should not have adverse reactions to ketamine or other listed medical conditions that could interfere with the study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but it mentions that you cannot be on certain medications like monoamine oxidase inhibitors. It's best to discuss your specific medications with the study team.

What is the safety track record for the combination use of MBCT and IV Ketamine?

Research shows that IV ketamine is generally well-tolerated for treating depression. Studies have found that ketamine can quickly reduce symptoms of depression, often within 72 hours. This rapid action helps many people feel better sooner than with traditional treatments.

Earlier studies noted some side effects of ketamine, such as dizziness, increased blood pressure, and confusion. However, these effects are usually short-lived, and people tend to recover from them quickly. Combining ketamine with Mindfulness-Based Cognitive Therapy (MBCT) might enhance its benefits, potentially leading to better results.

This trial is in Phase 4, indicating that ketamine has already passed several safety tests in earlier phases. This suggests the treatment is generally safe for humans. However, discussing any concerns with the trial team before participating is always important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of MBCT (Mindfulness-Based Cognitive Therapy) and IV Ketamine for treating depression because it offers a novel approach that differs from traditional antidepressants. Unlike standard medications that can take weeks to show effects, ketamine can potentially relieve symptoms in just hours or days, offering rapid relief. Additionally, MBCT helps patients by teaching mindfulness techniques that can reduce the risk of relapse, providing a holistic approach that addresses both immediate and long-term needs. This combination could effectively target treatment-resistant depression, offering new hope for individuals who haven't found success with existing therapies.

What evidence suggests that the combination of MBCT and IV Ketamine could be effective for depression?

Research shows that using IV ketamine with Mindfulness-Based Cognitive Therapy (MBCT) can significantly alleviate depression. Studies have found that ketamine quickly reduces depression levels. MBCT teaches mindfulness, which can gradually enhance mood. Participants who have tried these treatments together experienced substantial reductions in depression and anxiety. This combination has proven effective for many who haven't responded to other treatments, suggesting it could benefit more individuals. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with moderate to severe depression who have not improved after at least one antidepressant treatment. Participants must be able to understand English and follow the study's procedures, without a history of adverse reactions to ketamine or major health issues like heart disease, uncontrolled hypertension, or severe liver/renal disorders.

Inclusion Criteria

Adults age 18-65

Moderate to severe level of current depressive symptoms (MADRS score ≥20)

Capacity to consent and comply with study procedures, including sufficient proficiency in English

Exclusion Criteria

Pregnant or planning to become pregnant during the study period

Heart disease as indicated by history, abnormal ECG, previous cardiac surgery

Hypertension (>160/100)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ketamine infusion combined with Mindfulness-Based Cognitive Therapy (MBCT) for depression

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combination use of MBCT and IV Ketamine

Trial Overview The study tests combining IV ketamine, known for its rapid antidepressant effects, with Mindfulness-Based Cognitive Therapy (MBCT) as an initial and ongoing treatment for depression. The goal is to see if this combination can help alleviate symptoms more effectively than previous treatments.

How Is the Trial Designed?

Group I: Ketamine-MBCT Intervention Experimental Treatment 1 Intervention

One Arm: Combination of MBCT with a single ketamine infusion

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4609854/

Ketamine, Transcranial Magnetic Stimulation, and ... We present a review of rTMS, ketamine, and MBCT and also report efficacy of a depression specific, innovative, and translational model of Yoga and mindfulness ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05950711

Ketamine-Assisted Mindfulness-Based Cognitive Therapy ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9207256/

Ketamine Assisted Psychotherapy: A Systematic Narrative ... The results showed significant decreases in anxiety and depression scores as measured by the Hamilton Anxiety Scale (HAM-A) and the Beck ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1642025/full

Mindfulness, music, visual occlusion in ketamine therapy ... Results: Depression scores improved significantly and similarly across both groups. However, adding combined sensory interventions to ketamine ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2015/842817

Ketamine, Transcranial Magnetic Stimulation, and ... DepS Y-MBCT as an adjunctive treatment successfully ameliorated TRD symptoms in 27/32 patients in an open label pilot trial in TRD patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05950711?locStr=United+States&country=United+States&aggFilters=status%3A

Ketamine-Assisted Mindfulness-Based Cognitive Therapy ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9010394/

Ketamine treatment for depression: a review - PMC Compared to saline infusion, ketamine significantly improved depressive symptoms within 72 h [22]. A subsequent, adequately powered, randomized, ...

8. withpower.com withpower.com/trial/phase-4-major-depressive-disorder-mdd-2-2022-071cf

MBCT + IV Ketamine for Depression · Info for Participants 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 ...

9. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.868103/pdf

Toward Synergies of Ketamine and Psychotherapy Ketamine assisted psychotherapy (KAP): patient demographics, clinical data and outcomes in three large practices administering ketamine with ...