This open-label pilot trial (n=25) will assess the safety, tolerability, and clinical effects of intranasal ketamine (IN) treatment in patients with Ultra-Resistant Depression (URD) who have not responded to convulsive therapy.
The study, sponsored by the Centre for Addiction and Mental Health, aims to explore the efficacy of IN ketamine in improving depressive symptoms, suicidal ideation, and quality of life in patients with URD. Participants are adults diagnosed with non-psychotic major depressive disorder (MDD) who did not respond to at least eight sessions of convulsive therapy or could not tolerate the therapy. The trial will use a combination of Transcranial Magnetic Stimulation (TMS) neurophysiological tools with electromyography (EMG) and electroencephalography (EEG) to investigate biomarkers of ketamine’s antidepressant effect, focusing on cortical excitation and inhibition. The study started in October 2021 and completed in July 2023, with primary outcomes measured through changes in depressive symptoms from baseline.
Trial Details
Despite the known efficacy of pharmacotherapy (i.e. antidepressants) and psychotherapeutic interventions in treating depressive disorders, research evidence suggests that 20% to 40% of patients with major depressive disorder (MDD) do not respond adequately to such treatments. These patients are diagnosed with Treatment-Resistant Depression (TRD), and are sometimes treated with convulsive therapy. However, about 10-30% of TRD patients do not respond to convulsive therapy, and are thus diagnosed with Ultra-Resistant Depression (URD). Using an open label pilot study involving subjects, this trial aims to assess the safety, tolerability, and clinical effects of intranasal ketamine (IN) treatment in patients who do not respond to convulsive therapy. Intranasal ketamine (IN) treatment approach has shown promising therapeutic outcomes for patients with TRD, but has not yet been studied on patients with URD.Trial Number NCT05137938