An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
Open-label single-group expanded access esketamine programme (TRD) providing intranasal esketamine (56 or 84 mg flexible dosing) to collect additional safety and quality-of-life data (target n=41).
Details
Expanded access, single-group programme providing intranasal esketamine for participants with treatment-resistant depression who have no other treatment alternatives; dosing is flexible (induction twice weekly then maintenance weekly or twice weekly per investigator).
Primary aim is to provide access and collect safety and quality-of-life data; eligibility requires psychiatrist-verified TRD, medical stability, and prior nonresponse to multiple antidepressant strategies.
Assessments include safety labs, vitals and ECG prior to dosing and ongoing monitoring during the induction and maintenance phases.