This completed interventional trial (n=20) conducted in Ireland by the Department of Psychiatry aimed to assess the efficacy and safety of intravenous ketamine in patients with Selective Serotonin Reuptake Inhibitor (SSRI)-Resistant Depression (TRD).
The trial spanned approximately one year, from August 8, 2011, to March 23, 2012. The trial, identified by the EudraCT number 2011-003654-40 and Sponsor’s Protocol Code Number APC031, involved the use of the anaesthetic ketamine for treating depression in subanaesthetic doses.
The primary objective was to evaluate if weekly IV ketamine treatment over three weeks could relieve depressive symptoms in SSRI-resistant patients. Secondary objectives included assessing biomarkers such as cytokines, tryptophan metabolism, and endocrine parameters pre and post-ketamine treatment.
The trial included adults aged 18 to 65 years who had major depression according to DSM-IV criteria and had failed an adequate trial of an SSRI antidepressant for at least six weeks. The end of the trial was marked by the completion of 20 patients’ sessions and evaluation two weeks post-last ketamine infusion. The study received authorization from the Competent Authority on September 9, 2011, and had a favourable Ethics Committee Opinion on October 21, 2011.
Results can be found here.
Trial Details
Completed trial (n=20) in Ireland (EudraCT: 2011-003654-40) by the Department of Psychiatry tested the efficacy and safety of intravenous ketamine in SSRI-Resistant Depression over a year (Aug 8, 2011 - Mar 23, 2012). Primary objective: assess ketamine's potential to relieve depressive symptoms. Secondary objectives included biomarker analysis. Subjects (18-65 years) had DSM-IV major depression and SSRI treatment failure. Trial concluded after 20 patients, with evaluation two weeks post-last ketamine infusion. Authorized by Competent Authority on Sep 9, 2011, with a favourable Ethics Committee Opinion on Oct 21, 2011.Trial Number 2011-003654-40