Key Takeaways
Extended Takeaways
- Long-term exposure targets were achieved, with 364 patients dosed for 6 months and 136 for 12 months, giving clinicians a larger safety dataset than prior prolonged ketamine reports in treatment-resistant depression.
- During maintenance, dosing could often be reduced: 38.1% were maintained on every-other-week dosing, while 24.0% required weekly dosing and 37.8% switched more than once between schedules based on symptom severity.
- Blood pressure elevations were usually transient, peaking around 40 minutes postdose and returning close to predose values by 1.5 hours; acute hypertension occurred in 33/802 patients (4.1%), and 4 patients met discontinuation criteria due to elevated BP.
- Urinary monitoring did not show a signal for ketamine-type cystitis despite prolonged exposure: there was no case of interstitial/ulcerative cystitis, 5 adverse events of cystitis resolved while treatment continued, and UTI was reported in 65 patients (8.1%).
- Sedation events were uncommon at the session level, with MOAA/S ≤ 3 reported in 1.8% and 0.5% of dosing sessions in the IND and OP/MAINT, respectively; even the deepest sedation episodes resolved spontaneously without ventilation or resuscitation.
- Among patients entering induction, antidepressant improvement was substantial, with a mean [SD] MADRS change of −16.4 [8.76]; among responders who continued into optimization/maintenance, symptom control was largely preserved, with mean [SD] change from OP/MAINT baseline to endpoint of 0.3 [8.12].
