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Ketamine for Major Depressive Disorder
Phase < 1
Waitlist Available
Led By Balwinder Singh
Research Sponsored by Mayo Clinic
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 24 hour
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial will help determine if the levels of GABA and glutamate in the brain are associated with remission from depression after ketamine treatment.
Who is the study for?
This trial is for adults aged 18-65 with major depressive disorder or bipolar depression, who have not responded to at least two previous treatments. They must score ≥15 on the PHQ-9 depression scale and be able to understand the study's requirements. Exclusions include a BMI >40, certain medication use, recent ketamine treatment for depression, specific medical conditions like GERD or brain injury, and any active substance abuse.
What is being tested?
The study tests if changes in ACC GABA and glutamate levels in the brain after taking ketamine are linked to remission of depression symptoms. It also looks at whether these changes correlate with metabolite levels in the body. Participants will receive ketamine infusions and undergo MRS imaging.
What are the potential side effects?
Ketamine can cause side effects such as disorientation, dizziness, nausea, increased blood pressure and heart rate shortly after infusion. Long-term side effects may include cognitive issues or bladder problems but are less common.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate a correlation between percent change in ACC GABA and Glutamate/Glx levels (baseline to peak) with a change in MADRS (baseline to 24 hours).
To evaluate percent change in the anterior cingulate cortex (ACC) GABA and Glutamate (baseline to peak) during a 40-minute IV ketamine infusion and remission (MADRS ≤9) at 24 hour
Secondary study objectives
To compare the percent change in peripheral GABA/Glutamate levels between remitters and non-remitters
To evaluate the correlation between percent change in peripheral GABA and glutamate levels with a change in MADRS scores.
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: KetamineExperimental Treatment1 Intervention
Open-label, non-randomized
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,127 Total Patients Enrolled
40 Trials studying Depression
3,567 Patients Enrolled for Depression
Balwinder SinghPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received ketamine treatment for depression in the last 2 months.You have a condition called gastroesophageal reflux disease (GERD), which affects your stomach and esophagus.You have been diagnosed with Complex Regional Pain Syndrome (CRPS).You have a fear of enclosed spaces (claustrophobia).You have experienced a head injury that made you lose consciousness.You have a condition that affects your learning or thinking abilities.Your main diagnosis is a personality disorder.You have been diagnosed with schizophrenia, schizoaffective disorder, post-traumatic stress disorder, or currently experiencing severe symptoms of psychosis.You are currently receiving treatments like TMS, vagal nerve stimulation, or deep brain stimulation for depression.You have been diagnosed with confusion or brain-related problems in the past year.You have tried using ketamine in the past to treat your depression symptoms, but it did not work well or you had trouble tolerating it.You cannot take certain medications that affect the brain chemicals glutamate or GABA for two weeks before starting the study.You have a history of substance abuse, but you can still participate if you have been completely free from substance use for more than a year.You have had electroconvulsive therapy (ECT) in the past year.You have a problem with your memory or thinking abilities, as diagnosed by a doctor.You have a mental health condition other than anxiety that requires treatment with antidepressant medication.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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