Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression
This open-label trial (n=60) aims to assess the efficacy and safety of repeated subanesthetic maintenance doses of intravenous (IV) ketamine in patients with treatment-resistant bipolar depression (TRBD) over a period of twelve weeks.
Details
Open-label, single-arm 12-week extension (n=60) of a parent double-blind RCT testing flexible adjunctive IV ketamine infusions for participants with treatment-resistant bipolar depression who responded or remitted after an acute course.
Flexible dosing between 0.5–1.0 mg/kg administered over 40 minutes, given on a flexible schedule every 2–4 weeks with up to six infusions over 12 weeks; primary outcome is change in MADRS from baseline to week 12.
Secondary outcomes include response and remission rates, safety and tolerability (including treatment-emergent mania), suicidality, anxiety, quality of life, function and duration of antidepressant effects.