This double-blind, placebo-controlled therapeutic exploratory trial (n=80) investigates the effectiveness of a single intravenous application of ketamine at subanaesthetic doses in patients with treatment-resistant major depression (TRD).
The study, conducted by the Medical Faculty, University Magdeburg, Germany, aims to assess improvement in Hamilton Depression Rating Scale (HAMD) scores as the primary endpoint. Secondary objectives include exploring predictive biomarkers for treatment response and monitoring changes in glutamine concentrations using MR spectroscopy.
The trial, with a duration of 18 months, has been authorised by the German Competent Authority and received a favourable Ethics Committee opinion on January 25, 2012. The trial concluded on April 22, 2016.
Trial Details
This completed therapeutic exploratory trial (n=80) examined the efficacy of a single intravenous ketamine dose in treating treatment-resistant major depression. Conducted in Germany, the study assessed improvement in Hamilton Depression Rating Scale (HAMD) scores, explored predictive biomarkers, and monitored glutamine concentrations. Authorized by the German Competent Authority and with Ethics Committee approval on January 25, 2012, the trial concluded on April 22, 2016.Trial Number 2010-023414-31