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NMDA Receptor Antagonist
Intravenous Ketamine for Major Depressive Disorder
Phase 1 & 2
Waitlist Available
Led By Rebecca Price, PhD
Research Sponsored by Rebecca Price
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 80min post-infusion
Awards & highlights
Study Summary
This trial will test whether mindfulness training enhances the effects of ketamine for depression.
Eligible Conditions
- Major Depressive Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 80min post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~80min post-infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Montgomery-Asberg Depression Rating Scale
State Mindfulness Scale
Secondary outcome measures
Daily Spiritual Experience Scale
Hood Mysticism Scale
Mindful Attention Awareness Scale
+2 moreOther outcome measures
Awe Experience Scale
Dual probe video task
Sustained Attention Response Task (SART) omission errors
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous Ketamine + Mindfulness ExercisesExperimental Treatment2 Interventions
Group II: Intravenous Ketamine + Academic ExercisesActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous Ketamine
2021
Completed Phase 2
~60
Brief Mindfulness Exercises
2022
Completed Phase 2
~50
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Who is running the clinical trial?
Rebecca PriceLead Sponsor
7 Previous Clinical Trials
775 Total Patients Enrolled
Rebecca Price, PhDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with bipolar disorder, psychosis, or autism spectrum disorder at any point in your life.You have had a bad reaction or allergy to ketamine in the past.You are taking certain medications that affect specific receptors in the brain, such as glutamate or opioid receptors. However, one medication called lamotrigine is allowed because it does not affect the safety or effectiveness of the study drug.You are currently taking medications like St. John's Wort, theophylline, tramadol, or metrizamide.You have a score of 14 or higher on the Hamilton Depression Rating Scale (modified Ham-D).You have been practicing mindfulness meditation for more than one hour per week, on average, for at least the past six months.You are between the ages of 18 and 65 years.You currently have a serious problem with using drugs or alcohol.You are currently experiencing severe mental health issues that require immediate treatment.You have undergone electroconvulsive therapy (ECT) within the last 2 months before the screening.You have had one or more seizures without a clear cause that has been resolved.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous Ketamine + Academic Exercises
- Group 2: Intravenous Ketamine + Mindfulness Exercises
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05168735 — Phase 1 & 2
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