Rochester, MNNCT06668571Now EnrollingIRB Ready

Depressive Disorder, Treatment-Resistant Clinical Trial in Rochester, MN

Access cutting-edge depressive disorder, treatment-resistant treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by Mayo Clinic

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Expert Care in Rochester

Access depressive disorder, treatment-resistant specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related depressive disorder, treatment-resistant treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Depressive Disorder, Treatment-Resistant Study in Rochester

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.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Ability to provide informed consent
Meets diagnostic criteria for major depressive disorder without psychotic features per the SCID DSM-IV-TR
PHQ-9 total score ≥ 15 at screening
Treatment-resistant depression, as defined by failure of at least two previous antidepressant treatments within the current depressive episode. Failed antidepressant treatments can include pharmacotherapy for depression at an adequate dose for at least 8 weeks, trial of transcranial magnetic stimulation (TMS) or an acute series of at least 6 administrations of electroconvulsive therapy (ECT)
Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and criteria

Exclusion Criteria

Inability to speak English
Inability to provide consent or have a legal guardian
Patients with a BMI \> 40 kg/m2.
Personality disorder being the primary diagnosis
Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or active psychotic symptoms
Active post-traumatic stress disorder symptoms based on clinical assessment
Ongoing prescription of \> 2 mg lorazepam equivalents (total) daily, or morning dosing of any benzodiazepine at the time of assessment
Medications known to affect glutamate (i.e., Riluzole, Carbamazepine) or GABA (zaleplon, zolpidem, zopiclone, Valproate, Gabapentin, Pregabalin, tiagabine, and vigabatrin) are prohibited within two weeks prior to administration of study drug and at least 24 hours after last dose of study drug
Monoamine Oxidase Inhibitors (MAOIs) are prohibited two weeks prior to administration of study drug
Opioid antagonists (naltrexone, naloxone, nalmefene, methylnaltrexone, buprenorphine and naloxone combination) are prohibited within two weeks prior to administration of study drug and at least 24 hours after last dose of study drug
CYP3A4 inducers carbamazepine and modafinil are prohibited within two weeks prior to administration of study drug and at least 24 hours after last dose of study drug.
Currently undergoing TMS, vagal nerve stimulation, or deep brain stimulation as either an acute or maintenance treatment of depression
ECT in the past 6 months
Any active or unstable medical condition judged by the study psychiatrist as conferring too great a level of medical risk to allow inclusion in the study
A history of bleeding in the brain
Arteriovenous malformation or a history of aneurysm
Use of methamphetamine, cocaine, or cannabis. Abuse of stimulant (s) within the prior 12 months
Any current substance use disorder (excluding nicotine and caffeine). Note: Persons will be allowed to enroll in this study if their substance use is in complete (not partial) and sustained (\> 1 year) remission
History of traumatic brain injury that resulted in loss of consciousness with brain bleeding
History of tonic-clonic (grand mal) seizures
Developmental delay, intellectual disability, or intellectual disorder
Clinical or self-reported diagnosis of delirium, encephalopathy, or related clinical diagnosis within the prior 12 months
Minor or Major Neurocognitive disorder
Received ketamine treatment for depression within the prior 2 months
History of either poor antidepressive response to or poor tolerability of ketamine (any route of administration) when previously administered
History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 3 months
Hepatic insufficiency (2.5 X ULN for AST or ALT) within 3 months of consent, past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver
Gastroesophageal reflux disease that is poorly managed
A diagnosis of Complex Regional Pain Syndrome (CRPS)
Pregnancy, or nursing
History of claustrophobia with active symptoms that would interfere with the MRI
Any contraindication to MRI safety questionnaire
Poorly controlled hypertension.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT06668571) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Depressive Disorder, Treatment-Resistant Treatment Options in Rochester, MN

If you're searching for depressive disorder, treatment-resistant treatment options in Rochester, MN, this clinical trial (NCT06668571) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced depressive disorder, treatment-resistant specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all depressive disorder, treatment-resistant clinical trials near you to find additional studies recruiting in your area.

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