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MBCT + IV Ketamine for Depression
Phase 4
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing if ketamine and mindfulness therapy can help people with depression. #mentalhealth
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in MADRS score
Secondary study objectives
Change in PHQ9 score
Correlation between MADRS/PHQ9 score and Mystic experience scores
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketamine-MBCT InterventionExperimental Treatment1 Intervention
One Arm: Combination of MBCT with a single ketamine infusion
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,718 Total Patients Enrolled
16 Trials studying Depression
8,827 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain types of personality disorders that could make it difficult for you to receive treatment.Your body mass index (BMI) is higher than 32.You have a history of a condition called obstructive sleep apnea, which affects your breathing during sleep.You have difficulties with thinking or learning that would make it hard for you to take part in the study or complete the required tests.You have previously participated in a mindfulness-based program called MBCT or MBSR in a group setting.You currently have a problem with alcohol or drug addiction.You have already tried taking antidepressant medication for at least 6 weeks, but it didn't work for you.You have not had any bad reactions to ketamine in the past.You have a history of misusing or abusing ketamine, or have had a bad reaction to it in the past.You have attempted to harm yourself in the past month or currently have thoughts of hurting yourself.You have been diagnosed with major depressive disorder based on specific criteria from a diagnostic manual.You have been diagnosed with bipolar disorder, schizophrenia, any psychotic illness, active PTSD, dissociative disorders, current substance-induced mood disorder, OCD, eating disorder, or panic disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine-MBCT Intervention
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.