This open-label trial (n=200) investigates the efficacy of a single ketamine infusion combined with music for suicidal ideation (SI) during a depressive episode.
Randomized, factorial, open-label trial (n=200) testing IV ketamine 0.5 mg/kg over 40 minutes and a 60-minute music playlist (Nils Frahm) independently and combined versus treatment as usual in patients presenting with a depressive episode and suicidal ideation.
Primary outcome is reduction in suicidal ideation (SSI) at 4 weeks (response = ≥50% reduction); secondary outcomes include MADRS, SSI over follow-up, adverse events and safety monitoring. Participants monitored in ER/hospital with vitals every 15 minutes during and after infusion; weekly phone follow-up for 4 weeks.
IV ketamine 0.5 mg/kg infused over 40 minutes
Infused over 40 minutes
IV ketamine 0.5 mg/kg infused over 40 minutes with 60 minutes of music
Infused over 40 minutes
60 minutes playlist by Nils Frahm played during and around infusion
60 minutes of pre-planned music without ketamine
60 minutes playlist by Nils Frahm
Treatment as usual without ketamine or music
Treatment as usual (possible hospitalisation, medication, psychotherapy, outpatient referrals, suicide safety planning)