FrancophonIA/ELRC3.0 huggingface dataset:
English: At each treatment session, patients should be monitored under the supervision of a healthcare professional to assess when the patient is considered stable based on clinical judgement (see section 4.7).
Danish: Under hver enkelt behandlingssession skal patienten overvåges under supervision af en sundhedsperson for at vurdere, om patienten kan betragtes som stabil i henhold til en klinisk vurdering (se pkt.
English: Table 4: Baseline demographic characteristics for TRD3002, TRD3001, and TRD3005 (full analysis sets)
Danish: Tabel 4: Demografiske oplysninger ved baseline for TRD3002, TRD3001 og TRD3005 (fulde analysesæt)
English: For patients of Japanese ancestry, initial Spravato dose is 28 mg esketamine (day 1, starting dose, see Table 3).
Danish: Hos patienter af japansk afstamning er den indledende dosis af Spravato 28 mg esketamin (dag 1, startdosis, se tabel 3).
English: In elderly patients the initial Spravato dose is 28 mg esketamine (day 1, starting dose, see Table 2 above).
Danish: Hos ældre patienter er den indledende dosis af Spravato 28 mg esketamin (dag 1, startdosis, se tabel 2 herover).
English: Nasal use
Danish: nasal anvendelse
English: Weeks 1-4:
Danish: Uge 1-4: Startdag 1 dosis:
English: Nasal administration of 84 mg esketamine twice a week for 2 weeks did not affect the mean plasma AUC of oral bupropion (single 150 mg dose), a substrate of hepatic CYP2B6.
Danish: Nasal administration af 84 mg esketamin to gange ugentligt i 2 uger påvirkede ikke det gennemsnitlige AUC for oral bupropion (en enkelt dosis på 150 mg), et substrat for hepatisk CYP2B6.
English: Table 1: Recommended dosing for Spravato in adults <65 years Induction phase
Danish: Tabel 1: Anbefalet dosering af Spravato hos voksne < 65 år Induktionsfase
English: Skin and subcutaneous tissue disorders hyperhidrosis
Danish: Hud og subkutane væv hyperhidrose
English: ● blurred vision
Danish: ● sløret syn
English: Type-I glass vial with a chlorobutyl rubber stopper.
Danish: Type-I-glas hætteglas med en prop af klorbutylgummi.
English: ● If liquid drips out, dab nose with a tissue.
Danish: ● Hvis der forekommer næseflåd, tørres næsen med en serviet.
English: ● ever had slow or fast heartbeats causing shortness of breath, palpitations or chest discomfort,
Danish: ● på et eller andet tidspunkt har lidt af langsom eller hurtig hjerterytme, der har givet stakåndethed, hjertebanken eller ubehag i brystet, følelse af svimmelhed eller besvimelse
English: ● ever had lung problems causing breathing difficulty (pulmonary insufficiency), including
Danish: ● på et eller andet tidspunkt har haft lungeproblemer, der har givet vejrtrækningsbesvær (lungeinsufficiens), herunder kronisk obstruktiv lungesygdom (KOL)
English: ● pain when passing urine
Danish: ● smerte, når du lader vandet
English: Spravato is contraindicated in patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.3).
Danish: Spravato er kontraindiceret hos patienter, hvor en stigning i blodtrykket eller intrakranielt tryk udgør en alvorlig risiko (se pkt.
English: The potential for esketamine to have neurotoxic effects on developing foetuses cannot be excluded (see section 4.6).
Danish: Det kan ikke udelukkes, at esketamin potentielt kan have neurotoksiske effekter på fosterets udvikling (se pkt.
English: The pharmacokinetics of esketamine administered as a nasal spray was compared between elderly but otherwise healthy subjects and younger healthy adults.
Danish: Farmakokinetikken for esketamin administreret som næsespray blev sammenlignet mellem ældre, men i øvrigt raske forsøgspersoner og yngre, raske forsøgspersoner.
English: Patients in TRD3001 and TRD3002 initiated treatment with Spravato 56 mg plus a newly initiated daily oral AD or a newly initiated daily oral AD plus placebo nasal spray on day 1.
Danish: Patienterne i TRD3001 og TRD3002 påbegyndte behandling med Spravato 56 mg plus et nyligt initieret dagligt oralt AD eller et nyligt initieret dagligt oralt AD plus placebo næsespray på dag 1.
English: The Cmax and AUC∞ of esketamine were 8% higher and 103% higher, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment, relative to healthy subjects.
Danish: Cmax og AUC∞ for esketamin var henholdsvis 8% højere og 103% højere hos forsøgspersoner med moderat nedsat leverfunktion (Child-Pugh klasse B) i forhold til raske forsøgspersoner.
English: Table 2: Recommended dosing for Spravato in adults ≥65 years Induction phase
Danish: Tabel 2: Anbefalet dosering af Spravato hos voksne ≥ 65 år Induktionsfase
English: Baseline demographic and disease characteristics for patient in TRD3002, TRD3001, and TRD3005 are presented in Table 4.
Danish: De demografiske oplysninger og sygdomskarakteristika ved baseline for patienterne i TRD3002, TRD3001 og TRD3005 er vist i tabel 4.
English: In individuals who were dependent on ketamine, withdrawal symptoms of cravings, anxiety, shaking, sweating and palpitations have been reported upon discontinuing ketamine.
Danish: Hos personer, der har været afhængige af ketamin, er der indberettet abstinenssymptomer som f.eks. trang, angstanfald, rysteture, sveden og palpitationer efter seponering af ketamin.
English: The Cmax and AUC∞ of esketamine produced by a 28-mg doses were similar between subjects with Child-Pugh class A (mild) hepatic impairment and healthy subjects.
Danish: Cmax og AUC∞ for esketamin fremkaldt af doser på 28 mg var ensartede mellem forsøgspersoner med let nedsat leverfunktion (Child-Pugh klasse A) og raske forsøgspersoner.
English: The nasal spray device is a single-use device that delivers a total of 28 mg of esketamine, in two sprays (one spray per nostril).
Danish: Næsesprayanordningen er en engangsanordning, som afgiver i alt 28 mg esketamin i to pust (ét pust i hvert næsebor).
English: Spravato has not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Danish: Spravato er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: ● high blood pressure
Danish: ● højt blodtryk
English: Spravato + Oral AD (N=62)
Danish: Spravato + oralt AD (N=62)
English: Patients directly enrolled were administered Spravato (56 mg or 84 mg twice weekly) plus oral AD in a 4-week open label induction phase.
Danish: De patienter, der blev rekrutteret direkte, fik Spravato (56 mg eller 84 mg to gange ugentligt) plus oralt AD i en 4 uger lang ublindet induktionsfase.
English: For patients in stable response, the relapse rate based on Kaplan-Meier estimates during the 12- and 24-weeks double-blind follow up period was 21% and 21% for Spravato and 47% and 56% for placebo nasal spray, respectively.
Danish: For patienter med stabilt respons var recidivprocenten baseret på Kaplan-Meier-estimater under den 12 og 24 uger lange dobbeltblinde opfølgningsperiode henholdsvis 21% og 21% for Spravato og 47% og 56% for placebo næsespray.
English: Figure 1: Time to relapse in patients in stable remission in study TRD3003 (full analysis set)
Danish: Figur 1: Tid til recidiv hos patienter i stabil remission i studiet TRD3003 (fuldt analysesæt)
English: After the induction phase, patients received Spravato weekly for 4 weeks and starting from week 8, an algorithm (based on the MADRS) was used to determine the dosing frequency; patients in remission (i.e., MADRS total score was ≤ 12) were dosed every other week, however, if the MADRS total score increased to > 12, then the frequency was increased to weekly dosing for the next 4 weeks; with the objective of maintaining the patient on the lowest dosing frequency to maintain response/remission.
Danish: Patienter i remission (dvs. med en samlet MADRS-score ≤ 12) fik en dosis hver anden uge, men hvis den samlede MADRS-score steg til > 12, blev hyppigheden øget til ugentlig dosering i de næste 4 uger, med det mål at fastholde patienten på den laveste doseringshyppighed, der var i stand til at opretholde respons/remission.
English: The following EM should be provided to patients:
Danish: Følgende uddannelsesmateriale skal udleveres til patienterne:
English: In Study TRD3005, patients (≥ 65 years) initiated treatment with Spravato 28 mg plus a newly initiated daily oral AD or a newly initiated daily oral AD plus placebo nasal spray (day 1).
Danish: I studiet TRD3005 påbegyndte patienterne (≥ 65 år) behandling med Spravato 28 mg plus et nyligt initieret dagligt oralt AD eller et nyligt initieret dagligt oralt AD plus placebo næsespray (dag 1).
English: For patients in stable remission, the relapse rate based on Kaplan-Meier estimates during the 12- and 24-weeks double-blind follow up period was 13% and 32% for Spravato and 37% and 46% for placebo nasal spray, respectively.
Danish: For patienter i stabil remission var tilbagefaldsprocenten baseret på Kaplan-Meier-estimater under den 12 og 24 uger lange dobbeltblinde opfølgningsperiode henholdsvis 13% og 32% for Spravato og 37% og 46% for placebo næsespray.
English: Weeks 5-8: 56 mg or 84 mg once weekly
Danish: Uge 5-8: 56 mg eller 84 mg én gang om ugen
English: Other nasal spray products
Danish: Andre næsesprayprodukter
English: Stable Responders
Danish: Stabile respondere
English: 56 mg or 84 mg every 2 weeks or once weekly
Danish: 56 mg eller 84 mg hver anden uge eller én gang ugentligt
English: Pre-treatment of healthy subjects with nasal administration of mometasone furoate (200 mcg per day for 2 weeks with the last mometasone furoate dose administered at 1 hour prior to nasal administration of esketamine) had minor effects on the pharmacokinetics of esketamine.
Danish: Forbehandling af raske forsøgspersoner med nasal administration af mometasonfuroat (200 mikrog pr. dag i 2 uger med den sidste dosis mometasonfuroat administreret 1 time forud for nasal administration af esketamin) havde en mindre effekt på esketamins farmakokinetik.
English: The objective of this EM is to detail:
Danish: Målet med dette uddannelsesmateriale er at oplyse om:
English: ● muscle tremors
Danish: ● sitren i musklerne
English: A newly initiated open-label oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) was initiated on day 1 in all studies.
Danish: Et nyligt initieret ikke-blindet oralt AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin) blev initieret på dag 1 i alle studier.
English: Figure 2: Time to relapse in patients in stable response in study TRD3003 (full analysis set)
Danish: Figur 2: Tid til recidiv hos patienter med stabilt respons i studiet TRD3003 (fuldt analysesæt)
English: Study TRD3002 (N=223)
Danish: Studie TRD3002 (N=223)
English: Nasal administration of 84 mg esketamine twice a week for 2 weeks reduced the mean plasma AUC∞ of oral midazolam (single 6 mg dose), a substrate of hepatic CYP3A4, by approximately 16%.
Danish: Nasal administration af 84 mg esketamin to gange ugentligt i 2 uger reducerede gennemsnitlig plasmaAUC∞ for oral midazolam (en enkelt dosis på 6 mg), et substrat for hepatisk CYP3A4, med cirka
English: ● Hand device to patient.
Danish: ● Giv anordningen til patienten.
English: ● excessive sweating
Danish: ● kraftig sveden
English: After depressive symptoms improve, treatment is recommended for at least 6 months.
Danish: Det anbefales at fortsætte behandlingen i minimum 6 måneder efter forbedring af de depressive symptomer.
English: The active substance is esketamine.
Danish: Aktivt stof: esketamin.
English: Tell your doctor if you get any of the above while you are taking Spravato.
Danish: Fortæl det til din læge, hvis du oplever ovenstående, mens du tager Spravato.
English: Talk to your doctor before using Spravato if you are breast-feeding.
Danish: Tal med lægen, før du bruger Spravato, hvis du ammer.
English: EU/1/19/1410/001 (1 spray container) EU/1/19/1410/002 (2 spray containers) EU/1/19/1410/003 (3 spray containers) EU/1/19/1410/004 (6 spray containers)
Danish: EU/1/19/1410/001 (1 spraybeholder) EU/1/19/1410/002 (2 spraybeholdere) EU/1/19/1410/003 (3 spraybeholdere) EU/1/19/1410/004 (6 spraybeholdere)
English: It is important to make sure you come in for your scheduled appointments, so that this medicine is effective for you.
Danish: Hvis du holder op med at bruge Spravato Det er vigtigt, at du husker at møde op til dine planlagte aftaler, så medicinen kan virke for dig.
English: The median time to relapse for a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray group was 273 days, whereas the median was not estimable for Spravato plus oral AD, as this group never reached 50% relapse rate.
Danish: Den gennemsnitlige tid til tilbagefald for gruppen med et nyligt initieret oralt AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin) plus placebo næsespray var 273 dage, mens dette gennemsnit ikke kunne estimeres for Spravato plus oralt AD, da denne gruppe aldrig nåede en tilbagefaldsrocent på 50.
English: Other medicines and Spravato Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du bruger, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: In clinical studies, Spravato has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo and anxiety (see section 4.8).
Danish: I kliniske studier er det blevet rapporteret, at Spravato kan medføre somnolens, sedation, dissociative symptomer, perceptionsforstyrrelser, svimmelhed, vertigo og angstanfald (se pkt.
English: Pre-treatment with oral rifampicin, a potent inducer of the activity of multiple hepatic CYP enzymes such as CYP3A4 and CYP2B6, (600 mg daily for 5 days prior to esketamine administration) decreased the mean Cmax and AUC∞ values of esketamine administered as a nasal spray by approximately 17% and 28%, respectively.
Danish: Forbehandling med oral rifampicin, en potent induktor for aktiviteten af flere hepatiske CYP-enzymer som f.eks. CYP3A4 og CYP2B6, (600 mg dagligt i 5 dage forud for administration af esketamin) reducerede de gennemsnitlige Cmax- og AUC∞-værdier for esketamin administreret som næsespray med henholdsvis cirka 17 % og 28 %.
English: Study TRD3005 (N=137)
Danish: Studie TRD3005 (N=137)
English: • In patients with clinically significant or unstable cardiovascular or respiratory conditions, SPRAVATO should be administered in a clinical setting where equipment for cardiopulmonary resuscitation and staff trained in cardiopulmonary resuscitation are available;
Danish: • Hos patienter med klinisk signifikante eller ustabile hjerte-kar- eller respirationssygdomme skal Spravato administreres under kliniske forhold, hvor egnet genoplivningsudstyr og personale med uddannelse i hjerte-lungeredning er til rådighed.
English: ● Hypersensitivity to the active substance, ketamine, or to any of the excipients listed in section 6.1
Danish: ● Overfølsomhed over for det aktive stof ketamin eller over for et eller flere af hjælpestofferne anført i pkt.
English: 1 nasal spray device 6 nasal spray devices
Danish: 1 næsesprayanordning 6 næsesprayanordninger
English: Spravato (56 mg or 84 mg) + oral AD Oral AD + placebo nasal spray
Danish: Spravato (56 mg eller 84 mg) + oralt AD Oralt AD + placebo næsespray
English: Study TRD3001 (N=342)
Danish: Studie TRD3001 (N=342)
English: Do not use Spravato if you are breast-feeding.
Danish: Brug ikke Spravato, hvis du ammer.
English: The mean esketamine Cmax and AUC∞ values produced by a 28-mg dose were 21% and 18% higher, respectively, in elderly subjects (age range 65 to 81 years) compared with younger adult subjects (age range 22 to 50 years).
Danish: De gennemsnitlige Cmax- og AUC∞-værdier for esketamin, der fremkaldtes af en dosis på 28 mg var henholdsvis 21% og 18% højere hos ældre forsøgspersoner (aldersinterval 65 til 81 år) sammenlignet med yngre voksne forsøgspersoner (aldersinterval 22 til 50 år).
English: ● increased blood pressure
Danish: ● Stigning i blodtryk
English: Stable response
Danish: Stabilt respons
English: Pre-treatment with oral clarithromycin, an inhibitor of hepatic CYP3A4 activity, (500 mg twice daily for 3 days prior to and on the day of esketamine administration) increase the mean Cmax and AUC∞ of nasally administered esketamine by approximately 11% and 4%, respectively.
Danish: Forbehandling med oral clarithromycin, en hæmmer af hepatisk CYP3A4-aktivitet (500 mg to gange dagligt i 3 dage før og på dagen for administration af esketamin) øgede den gennemsnitlige Cmax og AUC∞ for nasalt administreret esketamin med henholdsvis ca. 11 % og 4 %.
English: The mean esketamine Cmax and AUC∞ values produced by an 84-mg dose were 67% and 38% higher in elderly subjects (age range 75 to 85 years) compared with younger adult subjects (age range 24 to 54 years).
Danish: De gennemsnitlige Cmax- og AUC∞-værdier for esketamin, der fremkaldtes af en dosis på 84 mg var henholdsvis 67% og 38% højere hos ældre forsøgspersoner (aldersinterval 75 til 85 år) sammenlignet med yngre voksne forsøgspersoner (aldersinterval 24 til 54 år).
English: Oral AD + Placebo Nasal Spray (N=59)
Danish: Oralt AD + placebo næsespray (N=59)
English: 2 nasal spray devices 3 nasal spray devices
Danish: 2 næsesprayanordninger 3 næsesprayanordninger
English: First dose was Spravato 56 mg + oral AD
Danish: Første dosis var Spravato 56 mg + oralt AD
English: Oral AD + Placebo Nasal Spray (N=86)
Danish: Oralt AD + placebo næsespray (N=86)
English: In these patients, Spravato should be administered in a setting where appropriate resuscitation equipment and healthcare professionals with training in cardiopulmonary resuscitation are available (see section 4.4).
Danish: Hos disse patienter skal Spravato administreres under forhold, hvor egnet genoplivningsudstyr og sundhedspersoner med uddannelse i hjerte-lungeredning er til rådighed (se pkt.
English: Pre-treatment of healthy subjects with oral ticlopidine, an inhibitor of hepatic CYP2B6 activity, (250 mg twice daily for 9 days prior to and on the day of esketamine administration) had no effect on the Cmax of esketamine administered as a nasal spray.
Danish: Forbehandling af raske forsøgspersoner med oral ticlopidin, en hæmmer af hepatisk CYP2B6-aktivitet (250 mg to gange dagligt i 9 dage før og på dagen for administration af esketamin) havde ingen effekt på Cmax for esketamin administreret som en næsespray.
English: EU/1/19/1410/001 (1 spray container) EU/1/19/1410/004 (6 spray containers)
Danish: EU/1/19/1410/001 (1 spraybeholder) EU/1/19/1410/004 (6 spraybeholdere)
English: Treatment discontinuation with Spravato does not require tapering off; based on data from clinical trials the risk of withdrawal symptoms is low.
Danish: Baseret på data fra kliniske forsøg er risikoen for abstinenssymptomer lav.
English: Each nasal spray device delivers 28 mg esketamine as two sprays.
Danish: Hver næsesprayanordning afgiver 28 mg esketamin som to pust.
English: In these patients, Spravato should be administered in a setting where appropriate resuscitation equipment and healthcare professionals with training in cardiopulmonary resuscitation are available.
Danish: Hos disse patiener skal Spravato administreres under forhold, hvor egnet genoplivningsudstyr og sundhedspersoner med uddannelse i hjerte-lungeredning er til rådighed.
English: EU/1/19/1410/002 (2 spray containers) EU/1/19/1410/003 (3 spray containers)
Danish: EU/1/19/1410/002 (2 spraybeholdere) EU/1/19/1410/003 (3 spraybeholdere)
English: Use in this population is not recommended (see sections 4.4 and 5.2).
Danish: Anvendelse hos denne population frarådes (se pkt.
English: Esketamine was not mutagenic with or without metabolic activation in the Ames test. Genotoxic effects with esketamine were seen in a screening in vitro micronucleus test in the presence of metabolic activation.
Danish: Esketamin var ikke mutagent hverken med eller uden metabolisk aktivering i Ames-testen.
English: Spravato has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo and anxiety during the clinical trials (see section 4.8).
Danish: Det er rapporteret, at Spravato har forårsaget somnolens, sedation, dissociative symptomer, perceptionsforstyrrelser, svimmelhed, vertigo og angstanfald i de kliniske forsøg (se pkt.
English: Missed treatment session(s)
Danish: Forpassede behandlingssessioner
English: Allergic rhinitis
Danish: Allergisk rhinitis.
English: Spravato 28 mg nasal spray, solution esketamine nasal use
Danish: Spravato 28 mg næsespray, opløsning esketamin nasal anvendelse
English: Spravato dosages were then maintained on 56 mg or titrated to 84 mg or matching placebo nasal spray administered twice-weekly during a 4-week double-blind induction phase.
Danish: Spravato-doserne blev derefter fastholdt på 56 mg eller titreret til 84 mg eller matchende placebo næsespray administreret to gange om ugen i en 4 uger lang dobbeltblind induktionsfase.
English: Tell your doctor if you get any of the below while you are using Spravato
Danish: Fortæl det til din læge, hvis du oplever nedenstående, mens du bruger Spravato
English: The median time to relapse for a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray group (88 days) was shorter compared to Spravato plus oral AD group (635 days).
Danish: Den gennemsnitlige tid til recidiv for gruppen med et nyligt initieret oralt AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin) plus placebo næsespray (88 dage) var kortere sammenlignet med gruppen, der fik Spravato plus oralt AD (635 dage).
English: Prepare device
Danish: Klargøring af anordningen
English: There is no clinical experience with esketamine administered as a nasal spray in patients with Child-Pugh class C (severe) hepatic impairment (see section 4.2 and 4.4).
Danish: Der er ingen klinisk erfaring med esketamin administreret som næsespray hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
English: In all three studies, a greater proportion of patients treated with Spravato plus oral AD were in remission at the end of the 4-week double-blind induction phase than for oral AD plus placebo nasal spray (Table 6).
Danish: I alle tre studier var andelen af patienter i remission ved afslutningen af den 4 uger lange induktionsfase større for de patienter, der blev behandlet med Spravato plus oralt AD end for dem, der fik oralt AD plus placebo næsespray (tabel 6).
English: ● ever had a condition called psychosis - where you believe in things that are not true (delusions)
Danish: ● på et eller andet tidspunkt har haft en sygdom, som kaldes psykose - hvor du tror, at uvirkelige ting er virkelige (vrangforestillinger) eller ser, føler eller hører ting, som ikke eksisterer (hallucinationer)
English: In patients with clinically significant or unstable cardiovascular or respiratory conditions, SPRAVATO should be administered in a setting where appropriate resuscitation equipment and healthcare professionals with training in cardiopulmonary resuscitation are available.
Danish: Hos patienter med klinisk signifikante eller ustabile hjerte-kareller respirationssygdomme skal Spravato administreres under forhold, hvor egnet genoplivningsudstyr og sundhedspersoner med uddannelse i hjerte-lungeredning er til rådighed
English: Nasally administered esketamine or placebo; oral AD = a newly initiated AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline)
Danish: Nasalt administreret esketamin eller placebo; oralt AD = et nyligt initieret AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin)
English: One spray delivered
Danish: Et pust afgivet
English: Oral AD + placebo nasal spray
Danish: Oralt AD + placebo næsespray
English: Relapse-prevention study
Danish: Recidivprofylaksestudie
English: Esketamine is extensively metabolised in the liver.
Danish: Esketamin metaboliseres ekstensivt i leveren.
English: Nasally administered Spravato or placebo; oral AD = a newly initiated AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline)
Danish: Nasalt administreret Spravato eller placebo; oralt AD = et nyligt initieret AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin)