This Phase I, dose escalation, safety study trial (n=24) evaluated the safety and tolerability of repeated ketamine infusions in adult patients with treatment-resistant depression (TRD).
Led by Dr Rupert McShane at Oxford Health NHS Foundation Trust, the trial aimed to explore the effectiveness of low-dose ketamine infusion in improving mood for individuals who had not responded to at least two adequate trials of antidepressants.
The study involved participants receiving Ketalar® (ketamine) intravenously over a 40-minute period, once weekly for three weeks in stage 1 and twice weekly for three weeks in stage 2.
The primary outcome measure was the safety and tolerability of repeated doses of ketamine, with secondary measures focusing on monitoring mood.
Recruitment began on 22/02/2010 and ended on 31/05/2012, with the overall study taking place within the same timeframe.
Trial Details
The ReD-KITE trial, led by Dr Rupert McShane at Oxford Health NHS Foundation Trust, investigated the safety and tolerability of repeated ketamine infusions in 24 adult patients with treatment-resistant depression. Participants received Ketalar® intravenously over three weeks, with primary focus on assessing safety and secondary measures to monitor mood. The study, conducted from February 2010 to May 2012, aimed to explore ketamine's antidepressant effects in individuals who hadn't responded to conventional treatments.Trial Number 2009-016941-25
Sponsors & Collaborators
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