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SUMMARY
- Clinical studies designed to evaluate the efficacy and/or safety of SPRAVATO in patients with comorbid dementia have not been performed.
- Although not performed in patients with dementia, the SPRAVATO clinical program did measure cognition in patients with treatment-resistant depression using Cogstate and Hopkins Verbal Learning Test-Revised (HVLT-R) tests, and scores generally remained stable or slightly improved from baseline.1-7 In the elderly subgroup (≥65 years of age) of 2 long-term safety trials, small increases of simple and choice reaction time occurred during the optimization/maintenance phase.5,6
- A case report described an 84-year-old female patient with dementia, behavioral disorder, and cerebrovascular cognitive impairment who presented with an exacerbation of anxiety-depressive and behavioral disorders. A cerebral MRI revealed age-related homogeneous cortico-subcortical atrophy and stage Fazekas 3 vascular leukopathy. Additionally, the patient scored 17/30 on a Mini Mental Status Exam (MMSE) with a recall of 0/3 words, and with profound attention disorder in the context of her anxiety-depressive condition. SPRAVATO 28 mg was initiated twice weekly for 4 weeks in addition to continuing venlafaxine 75 mg and starting Ericksonian hypnosis.8
- After 3 months, the patient demonstrated a significant reduction in anxiety-depressive symptoms and improvement in social interactions. Her MMSE remained stable (18/30) with an improvement in recall (2/3 words). Due to good neurocognitive and cardiovascular tolerance, a higher maintenance dose of SPRAVATO 56 mg was given at the 4th administration. The treatment was ongoing and administered regularly at the time of the report.
Literature Search
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File and/or other resources, including internal/external databases) pertaining to this topic was conducted on 28 October 2024.
1 | Fedgchin M, Trivedi M, Daly EJ, et al. Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019;22(10):616-630. |
2 | Popova V, Daly EJ, Trivedi M, et al. Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study. Am J Psychiatry. 2019;176(6):428-438. |
3 | Ochs-Ross R, Daly EJ, Zhang Y, et al. Efficacy and safety of esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression-TRANSFORM-3. Am J Geriatr Psychiatry. 2020;28(2):121-141. |
4 | Daly EJ, Trivedi MH, Janik A, et al. Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA Psychiatry. 2019;76(9):893-903. |
5 | Wajs E, Aluisio L, Holder R, et al. Esketamine nasal spray plus oral antidepressant in patients with treatment-resistant depression: assessment of long-term safety in a phase 3, open-label study (SUSTAIN-2). J Clin Psychiatry. 2020;81(3):19m12891. |
6 | Zaki N, Chen LN, Lane R, et al. Long-term safety and maintenance of response with esketamine nasal spray in treatment-resistant depression: final results of the SUSTAIN-3 study. Poster presented at: Psych Congress; September 6-10, 2023; Nashville, TN. |
7 | Morrison RL, Singh J, Daly E, et al. Effect of esketamine nasal spray on cognition in patients with treatment-resistant depression: results from four phase 3 studies. Int J Neuropsychopharmacol. 2024;27(11):pyae046. |
8 | Romani S, Jacquet B, Cohen D, et al. Esketamine for resistant depression in older people with cognitive impairment: a case report. Encephale. 2023;49(6):651-653. |