This completed interventional, single-site Phase II study (n=20) evaluated intravenous ketamine given weekly for three weeks in patients with SSRI‑resistant depression.
This single-site, non-randomised Phase II trial enrolled 20 patients with SSRI‑resistant major depression to receive intravenous ketamine once weekly for three weeks.
The primary outcome was change in depressive symptoms assessed two weeks after the final infusion; secondary objectives included measurement of biomarkers (cytokines, tryptophan metabolism and endocrine parameters) pre- and post-treatment and at longer-term follow-up.
Sponsor was the Department of Psychiatry, University College Cork; IMP was ketamine hydrochloride (Ketalar), provided by Pfizer Healthcare Ireland.
Intravenous ketamine administered weekly for three weeks in SSRI‑resistant depression (single-site, non-randomised).
Per-infusion dose not specified in registry; IMP concentration listed as '10' in EudraCT record (unit unclear).