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).
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.
Intranasal esketamine plus Almond Therapy (remote psychotherapy and supportive texts).
Almond Therapy: 8 remote therapy sessions (phone/video) plus supportive text messages; modules tailored by shared decision-making.
Intranasal administration (Spravato); 56 mg initial for up to 2 weeks then 56 mg or 84 mg; 8 doses over 28 days.
Intranasal esketamine plus treatment as usual (local therapy determined by treating physician).
Treatment as Usual may include CBT, supportive psychotherapy, mindfulness, exercise, support groups, etc.
Intranasal administration (Spravato); 56 mg initial for up to 2 weeks then 56 mg or 84 mg; 8 doses over 28 days.