Buyze, J.

Godinov, Y.

Haughey, S. Mulhern

Ito, T.

Kambarov, Y.

Luts, A.

Messer, T.

Nielsen, R.

Reif, A.

Rive, B.

Usankova, I.

von Holt, C.

Yagcioglu, A. E. Anil

English

    Aalborg UniversitetEsketamine nasal spray shows higher remission and response rates over 32 weeks oftreatment compared with quetiapine extended-release in patients with treatmentresistant depression: Results from ESCAPE-TRD, a randomised, phase IIIb clinical trialReif, A.; Yagcioglu, A. E. Anil; Luts, A.; Messer, T.; Nielsen, R.; Buyze, J.; Ito, T.; Kambarov,Y.; Haughey, S. Mulhern; Rive, B.; Usankova, I.; von Holt, C.; Godinov, Y.Published in:European PsychiatryDOI (link to publication from Publisher):10.1192/j.eurpsy.2023.272Creative Commons LicenseCC BY 4.0Publication date:2023Document VersionPublisher's PDF, also known as Version of recordLink to publication from Aalborg UniversityCitation for published version (APA):Reif, A., Yagcioglu, A. E. A., Luts, A., Messer, T., Nielsen, R., Buyze, J., Ito, T., Kambarov, Y., Haughey, S. M.,Rive, B., Usankova, I., von Holt, C., & Godinov, Y. (2023). Esketamine nasal spray shows higher remission andresponse rates over 32 weeks of treatment compared with quetiapine extended-release in patients withtreatment resistant depression: Results from ESCAPE-TRD, a randomised, phase IIIb clinical trial. EuropeanPsychiatry, 66(Suppl. 1), S90-S91. Article O0067. https://doi.org/10.1192/j.eurpsy.2023.272General rightsCopyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright ownersand it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.            - Users may download and print one copy of any publication from the public portal for the purpose of private study or research.            - You may not further distribute the material or use it for any profit-making activity or commercial gain            - You may freely distribute the URL identifying the publication in the public portal -Conclusions: Childhood trauma is linked with anger in adulthood,most strongly for trait anger and borderline personality traits. It isof clinical importance to explore childhood traumatic experienceand start trauma-focused interventions when appropriate.Disclosure of Interest: None DeclaredO0066ESKALE study, a French real-world study describingTRD patients with Esketamine nasal spray: finalanalysisL. Samalin1*, L. Mekaoui2, M. Rotharmel3, P. de Maricourt4,M.-A. CODET5 and E. Gaudre Wattinne51Department of Psychiatry, CHU Clermont-Ferrand, University ofClermont Auvergne, Clermont-Ferrand; 2Mental and Brain IllnessClinic, Sainte Anne Hospital GHU Paris, Paris; 3UniversityDepartment of Psychiatry, Therapeutic Centre of Excellence,Institute of Psychiatry, Rouvray Hospital Centre, Sotteville-lès-Rouen; 4Université Paris; Department of Psychiatry, ServiceHospitalo-Universitaire, GHU Paris Psychiatrie & Neurosciences,F-75014, Paris and 5Medical Affairs department, Janssen Cilag, Issyles Moulineaux, France*Corresponding author.doi: 10.1192/j.eurpsy.2023.271Introduction: Treatment resistant depression (TRD) affects a sub-stantial proportion of patients with depression and carries a largeunmet need. Esketamine nasal spray (NS), in combination with aselective serotonin reuptake inhibitor (SSRI) or serotonin norepin-ephrine reuptake inhibitor (SNRI), has been shown to reducedepressive symptoms and risk of relapse, in patients with TRD(Popova, V., et al. 2019. Am J Psychiatry; Daly, E.J., et al. 2019.JAMA Psychiatry). Esketamine NS has been authorised byEuropean Medicines Agency as treatment for resistant depressionsince December 2019. ESKALE, is the first French observationalstudy to describe TRD patients treated with Esketamine NS underreal-world settings and to provide data on this innovative solutionfor patients.Objectives: To describe patients with TRD at Esketamine NSinitiation and during the following 12-month period in real-worldclinical practice.Methods: ESKALE is a French, observational, multicentre, retro-spective study of adult patients with moderate to severe TRDdefined as a non-response to ≥ 2 oral antidepressant. Each patientwas included in one of the 3 cohorts according to Esketamine NSstart date: Temporary Authorisation for Use (ATUc) cohort, post-ATU cohort or post-launch period cohort. Data were collectedfrom medical records of patients treated with Esketamine NSbetween 10-29-2019 and 06-14-2022. Primary objective is todescribe patients’ profile and Esketamine NS conditions of use atesketamine initiation and during the 12-month period after eske-tamine initiation in real-world clinical practice (either patient hadstop or not the treatment). Secondary objectives are to describeEsketamine NS management, safety profile and patient pathway.Results: Two standard descriptive statistical interim analysis wereconducted and published in several conferences (Samalin L, et al.Presented at EPA Hybrid congress June 2022. P.2482; Samalin L,et al. Presented at ECNP Vienna, October 2022. P.0122). This finalanalysis describes the data collected from medical records ofpatients included in the study from 04-08-2020 to 06-30-2021.157 patients were included from 26 French centers, the majority(>65%) of patients were females. Average age was 49 years old with27 patients > 65 years old. Duration of the current depressiveepisode was up to 2,5 years (mean) with an average of more thanthree episode in the patient’s entire life (mean). At esketamineinitiation, 3 patients out of 4 were clinically perceived to have severedepression with a MADRS score of 32.0 (median). Patients hadmainly depression with anxious distress specifier. Esketamine NSdose at initiation was mainly 56mg.Conclusions: Eskale is the first French cohort study generatingreal-world evidence on treatment resistant depression patientstreated with Esketamine nasal spray. Results of the final analysisconfirmed the 2 interim analysis results already published.Disclosure of Interest: None DeclaredO0067Esketamine nasal spray shows higher remission andresponse rates over 32 weeks of treatment comparedwith quetiapine extended-release in patients withtreatment resistant depression: Results from ESCAPE-TRD, a randomised, phase IIIb clinical trialA. Reif1*, A. E. Anıl Yağcıoğlu2, A. Luts3, T. Messer4, R. Nielsen5,J. Buyze6, T. Ito7, Y. Kambarov8, S. Mulhern Haughey9, B. Rive10,I. Usankova11, C. von Holt12 and Y. Godinov131Department of Psychiatry, Psychosomatic Medicine andPsychotherapy, University Hospital Frankfurt, Frankfurt, Germany;2Department of Psychiatry, Hacettepe University Faculty ofMedicine, Ankara, Türkiye; 3ProbarE in Lund AB, Lund, Sweden;4Danuvius Klinik GmbH, Technische Universität München,Pfaffenhofen an der Ilm, Germany; 5Aalborg University Hospital,Aalborg, Denmark; 6Janssen Pharmaceutica NV, Beerse, Belgium;7Janssen EMEA, High Wycombe, United Kingdom; 8Janssen EMEA,Beerse, Belgium; 9Janssen EMEA, Dublin, Ireland; 10Janssen EMEA,Paris, France; 11Janssen EMEA, Moscow; 12Janssen EMEA, Neuss,Germany and 13Janssen EMEA, Sofia, Bulgaria*Corresponding author.doi: 10.1192/j.eurpsy.2023.272Introduction: Treatment resistant depression (TRD) is estimatedto affect 10–30% of patients with major depressive disorder(Al‑Harbi et al. Patient Prefer Adherence 2012; 6 369–88). Esketa-mine nasal spray (NS), in combination with a selective serotoninreuptake inhibitor (SSRI) or serotonin norepinephrine reuptakeinhibitor (SNRI), increases remission and response rates in patientswith TRD compared with placebo plus SSRI/SNRI (Popova et al.Am J Psychiatry 2019; 176 428–38). ESCAPE-TRD (NCT04338321)is the first randomised clinical trial to compare esketamine NS toquetiapine extended-release (XR), an antipsychotic augmentationtherapy for patients with TRD.Objectives: To explore the efficacy and safety of esketamine NScompared with quetiapine XR in TRD over 32 weeks (wks).Methods: In the ESCAPE-TRD phase IIIb open-label, rater-blinded trial, patients were randomised 1:1 to esketamine NS(56/84 mg; twice per wk, weekly or every 2 wks) or quetiapine XR(150–300 mg daily) both in combination with an ongoing SSRI/SNRI. Remission (Montgomery-Åsberg Depression Rating Scale[MADRS] total score of≤10) and response (≥50% improvement inS90 Oral Communicationhttps://doi.org/10.1192/j.eurpsy.2023.272 Published online by Cambridge University PressMADRS total score from baseline or MADRS≤10) rates wereanalysed over time using last observation carried forward. MADRSchange from baseline was analysed using Mixed Models forRepeated Measures (MMRM). The most common adverse events(AEs) leading to discontinuation are reported for patients whoreceived ≥1 dose of study medication.Results: At baseline, 336 patients were randomised to esketamineNS and 340 to quetiapine XR. A significantly higher percentage ofpatients in the esketamine NS group achieved remission (at eachvisit fromWk6 [p=0.008] onward) and response (at each visit fromDay 15 [p<0.001] onward) versus patients treated with quetiapineXR. Esketamine NS significantly improved MADRS score com-pared to quetiapine XR at each visit from Day 8 onwards, with anaverage difference over time in the least squares means totalMADRS score change from baseline of -2.4 (Figure). The mostcommon AEs leading to treatment discontinuation for esketamineNS were dizziness (n=2, 0.6%), dissociation (n=2, 0.6%) andvomiting (n=2, 0.6%), and for quetiapine XR were sedation (n=7,2.1%), weight increased (n=6, 1.8%) and somnolence (n=5, 1.5%).Image:Conclusions: Esketamine NS increased the percentage of patientsachieving response and remission and improved MADRS totalscore over time compared with quetiapine XR. Rates of discontinu-ation arising from themost commonAEs were generally lower withesketamine NS than quetiapine XR.Acknowledgements: We thank participating patients and all whoassisted with the study. This study was funded by Janssen; medicalwriting support was provided by Carolyn Walsh, PhD, CostelloMedical, UK.Disclosure of Interest: A. Reif Grant / Research support from:Medice, Consultant of: National Care Guidelines (NVL, S3) onmajor depression, bipolar disorder, ADHD and suicidal behaviour(aided in developing guidelines); boardmember of DGBS, DGPPN,ECNP and German Depression Foundation, Speakers bureau of:(and participated in advisory boards over the last 3 years) forCyclerion, Janssen, Medice, SAGE/Biogen and Shire/Takeda;received speaker’s honoraria from Das Fortbildungskolleg; , A. E.Anıl Yağcıoğlu Grant / Research support from: Participated as aninvestigator for Janssen, Speakers bureau of: (and participated inadvisory boards over the last 3 years) for Janssen and Abdi İbrahimOtsuka, A. Luts Speakers bureau of: (or participated in advisoryboards for or participated as an investigator) for Janssen-Cilag,Asarina Pharma, Bristol Meyer Squibb, Dr August Wolff GmbH &Co, Eli Lilly, Lundbeck, Pfizer, Allergan, Sunovion and Regeneron.,T. Messer Consultant of: National Care Guidelines (NVL, S3) onmajor depression (aided in developing guidelines), Speakers bureauof: (and participated in advisory boards) for Janssen-Cilag andOtsuka/Lundbeck, R. Nielsen Consultant of: Board member ofDSAL and IGSLi, Speakers bureau of: (or participated in advisoryboards, received research funds or participated as investigator overthe last 3 years) for Boehringer Ingelheim, Compass Pharmaceut-icals, Janssen-Cilag, Lundbeck, Otsuka, Sage and Teva Pharma-ceuticals, J. Buyze Employee of: Janssen, T. Ito Employee of:Janssen, Y. Kambarov Employee of: Janssen, S. Mulhern HaugheyEmployee of: Janssen, B. Rive Employee of: Janssen, I. UsankovaEmployee of: Janssen, C. von Holt Employee of: Janssen,Y. Godinov Employee of: JanssenO0068Improvement in Depression Symptoms Measured byMontgomery-Åsberg Depression Rating Scale andQuick Inventory of Depressive Symptomatology-SelfRated Items after RandomisedDouble-blindCOMP360Psilocybin Therapy for Treatment-resistant DepressionG. M. Goodwin, L. Marwood*, S. Mistry, A. Nowakowska,H. Simmons, J. Tsai, S. Williams, M. B. Young and E. MalievskaiaCOMPASS Pathways, London, United Kingdom*Corresponding author.doi: 10.1192/j.eurpsy.2023.273Introduction: COMP360 is a synthetic, proprietary, purified formof psilocybin in development for treatment-resistant depression(TRD) with FDA Breakthrough Therapy designation. In a recentphase IIb study, COMP360 psilocybin 25mg was superior to 1mgon change from baseline (CFB) to Week 3 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (primaryefficacy endpoint), when administered alongside psychologicalsupport. Quick Inventory of Depressive Symptomatology-SelfRated (QIDS-SR16) total score (exploratory efficacy endpoint)showed similar results.Objectives: To analyse changes in specific depression symptomsafter psilocybin treatment in the aforementioned study, as meas-ured by individual item scores on the MADRS and QIDS-SR16(range 0-6 and 0-3).Methods: Participants with TRD were randomised to single dosesof psilocybin 25mg (n=79), 10mg (n=75), or 1mg (n=79). Aremote, blinded rater assessed the MADRS at Baseline, Day2 (the day post-psilocybin), and Weeks 1, 3, 6, 9, and 12. TheQIDS-SR16 was self-rated at Baseline, Day 1, Day 2, and Weeks1, 2, 3, 6, 9, and 12. At each time point, descriptive statistics werecalculated for each MADRS and QIDS-SR16 individual item score.Results: At Week 3, MADRS items with the largest differences inmean CFB in the 25mg arm were Inability to Feel, ApparentSadness, Lassitude, and Reported Sadness. Greater improvementin the 25mg arm was apparent from Day 2 and remained to Week12 (Lassitude remained to Week 6 only). On the QIDS-SR16, theitemwith the largest difference inmean CFB atWeek 3 in the 25mgarmwas in Feeling Sad and remained evident toWeek 12 (Table 1).European Psychiatry S91https://doi.org/10.1192/j.eurpsy.2023.272 Published online by Cambridge University Press

Esketamine nasal spray shows higher remission and response rates over 32 weeks of treatment compared with quetiapine extended-release in patients with treatment resistant depression: Results from ESCAPE-TRD, a randomised, phase IIIb clinical trial

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Esketamine nasal spray shows higher remission and response rates over 32 weeks of treatment compared with quetiapine extended-release in patients with treatment resistant depression: Results from ESCAPE-TRD, a randomised, phase IIIb clinical trial

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