Comparing Early Effects of Intravenous Ketamine Versus Placebo Alongside Venlafaxine Treatment in Hospitalized Adults with Severe Unipolar Depression

What this Trial Is About

Major depressive disorder is a leading cause of disability worldwide, with current treatments like antidepressants often taking 2 to 6 weeks to show effects. This delay can lead to hospitalization for severe major depressive episodes MDE. Researchers are evaluating the early effects of intravenous ketamine, alongside standard venlafaxine treatment, in patients hospitalized with severe unipolar depression to potentially improve early treatment response and reduce risks such as suicidal ideation and long hospital stays. Participants in this study will receive either three doses of intravenous ketamine or placebo on days 1, 4, and 7, in addition to their usual venlafaxine treatment. The study compares ketamine to placebo as an add-on therapy to venlafaxine during this early treatment phase. The study is randomized and quadruple-blinded to assess the efficacy and safety of ketamine in this setting. During the study, participants will be closely monitored for depressive symptoms using tools like the Hamilton Depression Rating Scale HDRS, Beck Depression Inventory BDI, and Clinical Global Impression CGI at multiple time points up to 42 days. Safety parameters such as blood pressure, heart rate, respiratory rate, and side effects like nausea and dissociation will also be tracked. Additional assessments include hospitalization duration, suicidal ideation, anxiolytic use, biomarkers, and PET imaging in a subset of patients. The total follow-up period extends to 42 days after treatment initiation.

Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients