Actively Recruiting
Intravenous Ketamine for Treatment-Resistant Depression
Led by Mayo Clinic · Updated on 2025-10-14
30
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to to evaluate the relationships between peak (% change from baseline) central GABA and Glu levels during a 40-min IV ketamine or normal saline infusion utilizing fMRS, and change in peripheral GABA and Glu levels from baseline to 24-hr postinfusion utilizing LCMS, with baseline to 24-hr post-infusion change in depression (MADRS) in 30 TRD adults.
CONDITIONS
Official Title
Intravenous Ketamine for Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent
- Diagnosis of major depressive disorder without psychotic features per SCID DSM-IV-TR
- PHQ-9 score of 15 or higher at screening
- Treatment-resistant depression with failure of at least two antidepressant treatments in current episode
- Ability to understand ketamine effects and study objectives based on comprehension test
You will not qualify if you...
- Unable to speak English
- Unable to provide consent or lack legal guardian
- Body mass index over 40 kg/m2
- Primary diagnosis of personality disorder
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or active psychotic symptoms
- Active post-traumatic stress disorder symptoms
- Taking more than 2 mg lorazepam equivalents daily or morning benzodiazepines
- Use of medications affecting glutamate or GABA within two weeks before study drug and 24 hours after
- Use of monoamine oxidase inhibitors within two weeks before study drug
- Use of opioid antagonists within two weeks before study drug and 24 hours after
- Use of CYP3A4 inducers carbamazepine or modafinil within two weeks before study drug and 24 hours after
- Currently undergoing TMS, vagal nerve stimulation, or deep brain stimulation
- Electroconvulsive therapy within past 6 months
- Any active or unstable medical condition posing high medical risk
- History of brain bleeding, arteriovenous malformation, or aneurysm
- Use or abuse of methamphetamine, cocaine, cannabis, or stimulants within past 12 months
- Current substance use disorder except nicotine and caffeine, unless in full remission for over 1 year
- History of traumatic brain injury with loss of consciousness and brain bleeding
- History of tonic-clonic seizures
- Developmental delay, intellectual disability, or intellectual disorder
- Diagnosis of delirium, encephalopathy, or related condition in past 12 months
- Minor or major neurocognitive disorder
- Ketamine treatment for depression within prior 2 months
- Poor response or tolerability to prior ketamine treatment
- Hypothyroidism unless stable on medication and symptom-free for 3 months
- Liver insufficiency or past liver transplant or cirrhosis
- Poorly managed gastroesophageal reflux disease
- Diagnosis of Complex Regional Pain Syndrome
- Pregnancy or nursing
- Claustrophobia with active symptoms interfering with MRI
- Any contraindication to MRI safety
- Poorly controlled hypertension
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Nicole Reinicke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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