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SUMMARY
- Clinical studies designed to evaluate the efficacy and/or safety of SPRAVATO in patients with comorbid glaucoma have not been performed.
- SPRAVATO clinical program excluded patients with untreated glaucoma, brain injury, increased intraocular or intracranial pressure, or perforating eye injury. In addition, the treatment-resistant depression (TRD) program excluded patients with planned eye surgery.1-7
- A case series described 2 female patients with TRD and glaucoma - one with bilateral normal-tension glaucoma and one with congenital glaucoma - who showed sustained symptom improvement after treatment with SPRAVATO and brexpiprazole. There was no evidence of worsening glaucoma reported in either case. In the case of the patient with normal-tension glaucoma, she experienced double vision within 10 minutes of SPRAVATO administration with spontaneous resolution within 50 minutes of observation.8
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 29 July 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 | Fu DJ, Ionescu DF, Li X, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). J Clin Psychiatry. 2020;81(3):19m13191. |
| 7 | Ionescu DF, Fu DJ, Qiu X, et al. Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of a phase 3, double-blind, randomized study (ASPIRE II). Int J Neuropsychopharmacol. 2021;24(1):22-31. |
| 8 | Chan LF, Woon LSC, Shukor NAM, et al. Case report: effectiveness of brexpiprazole and esketamine/ketamine combination: a novel therapeutic strategy in five cases of treatment-resistant depression. Front Psychiatry. 2022;13:890099. |
