Ketamine for Relapse Prevention in Recurrent Depressive Disorder
Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for depression relapse prevention in persons at high risk. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.
Details
Participants admitted to St Patrick's University Hospital with DSM-IV recurrent unipolar depression receive treatment-as-usual and, if meeting response criteria, are randomised to four two-weekly infusions of ketamine (0.05 mg/kg) or midazolam (0.045 mg/kg) administered by an anaesthetist.
Outcomes include relapse over six months, physical, psychotomimetic and cognitive monitoring during infusions (observation ~200 minutes), and biomarker/epigenetic measures from blood sampled at multiple time points.
Design: randomised, double-blind, parallel-group pilot with block randomisation; anaesthetist administering infusions was unblinded while participants and raters were masked.