Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression (ZYL-730-01)
Single-blind, randomised Phase II trial (n=6, terminated) comparing Almond Therapy plus intranasal esketamine to Treatment as Usual plus intranasal esketamine over 28 days; esketamine given twice-weekly for 8 doses (56 mg initial, then 56 or 84 mg).
Details
Randomised, single-blind, parallel-group Phase II study in patients with treatment-resistant major depressive disorder assessing Almond Therapy adjunctive to approved intranasal esketamine versus treatment as usual with intranasal esketamine over 28 days.
Participants receive intranasal esketamine twice-weekly for a total of 8 doses (56 mg initial for up to 2 weeks then 56 mg or 84 mg). Almond Therapy comprises 8 remote therapy sessions plus supportive text messages; independent assessors conduct five telephone MADRS checks.