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RecruitingDepressive Disorder, Treatment-ResistantTreatment Resistant Depression (TRD)

Intravenous Ketamine for Treatment-Resistant Depression

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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

You may qualify 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. 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

You may not qualify 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
  • ✕ 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

Where it's recruiting

Minnesota

Rochester

Source: ClinicalTrials.gov · NCT06668571 · last updated 2025-10-14