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Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder
Sponsor: Centre Hospitalier Universitaire Vaudois
Summary
The goal of this clinical trial is to test the efficacy of lactate (a natural substance) in combination with standard antidepressant treatment, in patients hospitalized for a major depressive episode. The main question\[s\] it aims to answer are: * does lactate diminishes depression severity when administered in combination with antidepressant ? * is it feasible to test lactate treatment in a large-scale clinical trial ? Participants will receive lactate intravenously daily (20 min infusion) for 5 days during hospitalisation (together with the standard antidepressant treatment). Researchers will compare with a group receiving a placebo instead of lactate to see if lactate has antidepressant effects.
Official title: A Feasibility Single-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Feasibility of Conducting a Full-scale Randomized Controlled Trial (RCT) Assessing Efficacy of Lactate as Adjunctive Therapy in Hospitalized Patients With Major Depressive Disorder
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-01
Completion Date
2028-01
Last Updated
2023-12-13
Healthy Volunteers
No
Conditions
Interventions
Sodium lactate
2 mmol/kg, intravenous, daily for 5 consecutive days
Placebo
intravenous, daily for 5 consecutive days