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New treatment option for Depressive Disorder, Treatment-Resistant
Official title Intravenous Ketamine for Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT06668571
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for depressive disorder, treatment-resistant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and criteria
You likely can't join if
- 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
See the full eligibility 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...
- Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and 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...
- 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...
- 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 side effects 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.