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Recruiting Phase 2 NCT06668571

Intravenous Ketamine for Treatment-Resistant Depression

Trial Parameters

Condition Depressive Disorder, Treatment-Resistant
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-02-10
Completion 2027-12-31
Interventions
KetamineNormal Saline

Brief Summary

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.

Eligibility Criteria

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

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