Naim Zaki

2 papers in the library · 154 citations · publishing 2023-2025

Papers

Long-Term Safety and Maintenance of Response With Esketamine Nasal Spray in Participants With Treatment-Resistant Depression: Interim Results of the SUSTAIN-3 Study

Neuropsychopharmacology May 12, 2023 Naim Zaki, Li Chen, Rosanne Lane et al. 122 citations

Adults with treatment-resistant depression who continued esketamine nasal spray plus an oral antidepressant in a long-term extension study (SUSTAIN-3) showed sustained improvement in depression ratings over up to 4.5 years. Among 1148 participants, common side effects included headache, dizziness, nausea, dissociation, somnolence, and nasopharyngitis. Depression scores dropped during the initial four-week induction phase and remained low during maintenance; about 46% of participants were in remission at the maintenance phase endpoint. No new safety concerns emerged with long-term, intermittent dosing.

DOI: 10.1038/s41386-023-01577-5 Full text Treatment-resistant depression Major depressive disorder Tolerability Maintenance therapy +8

Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study.

The international journal of neuropsychopharmacology June 6, 2025 Naim Zaki, Li Nancy Chen, Rosanne Lane et al. 32 citations

In a long-term extension study (SUSTAIN-3) involving 1,148 adults with treatment-resistant depression, esketamine nasal spray combined with an oral antidepressant was evaluated for safety and efficacy over up to 79 months (median 45.8 months). Common adverse events included headache (36.9%), dizziness (33.9%), and nausea (33.6%). Nine participants died, with causes including COVID-19 and suicide. Depressive symptoms, measured by the MADRS, improved during the initial induction phase (average reduction of 12.8 points) and this improvement was maintained during the optimization/maintenance phase. At the end of maintenance, 49.6% of participants were in remission. No new safety concerns emerged, and depression improvement generally persisted for those continuing treatment.

DOI: 10.1093/ijnp/pyaf027 Full text Treatment-resistant depression Efficacy Long-term Safety +5