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Summary
- Across the SPRAVATO phase 3 studies in treatment-resistant depression, patients receiving psychotherapy before entering the trials (including cognitive behavioral therapy [CBT]) could continue receiving psychotherapy during the trials.1
- CBT must have been ongoing for the last 3 months prior to the screening/prospective, observational phase. Except for new CBT, which was prohibited, new psychotherapy was allowed during these studies.1
- During the phase 3 program, one study removed the restriction related to CBT and allowed for all previous forms of psychotherapy to be continued or newly initiated during the study.2
- The clinical trial program in major depressive disorder with suicidal ideation and intent provided all patients with standard-of-care treatment, which included psychotherapy.3
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 20 September 2024.
1 | 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. |
2 | Data on File. Esketamine. Protocol ESKETINTRD3004; Phase 3 Amendment. Janssen Research & Development, LLC; 2016. |
3 | 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. |