Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 8, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT05046184). This is a study registration, not published results. Lead sponsor: University of Texas Southwestern Medical Center. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 104 participants (ACTUAL). Conditions: Major Depressive Disorder, Healthy Controls. Interventions: DRUG: Ketamine Hydrochloride; DRUG: Midazolam injection. Primary outcome measures: Resting State Functional Connectivity. , Baseline; Striatal Response to Frustrative Nonreward (FNR). , Baseline; Treatment-related Change in Striatum-habenula Functional Connectivity. , Assessed at baseline and end of treatment. See outcome measure 1 for baseline visit reporting; Treatment-related Change in Striatal Response to FNR. , Baseline, at 14 days. See outcome measure 2 for baseline timepoint data. Brief summary: The study is investigating dysfunctions in neurocircuitry in regards to irritability with healthy controls (HC) and individuals with Major Depressive Disorder (MDD) by performing MRIs. The MDD group will also be randomized to receive ketamine or midazolam to investigate changes post-treatment in neurocircuitry with regards to irritability.