FrancophonIA/ELRC3.0 huggingface dataset:
English: Sycrest is not approved for the treatment of patients with dementia-related psychosis and is not recommended for use in this particular group of patients.
Slovenian: Zdravilo Sycrest ni odobreno za zdravljenje bolnikov s psihozo v okviru demence in ni priporočljivo za uporabo pri tej specifični skupini bolnikov.
English: Maintenance of effect during the episode after 12 weeks of randomised treatment was demonstrated in this trial.
Slovenian: To preskušanje je pokazalo ohranjanje učinka med posamezno epizodo po 12. tednih randomiziranega zdravljenja.
English: Asenapine may induce orthostatic hypotension and syncope, especially early in treatment, probably reflecting its α1-adrenergic antagonist properties.
Slovenian: Asenapin lahko povzroči ortostatsko hipotenzijo in sinkopo, še posebej na začetku zdravljenja, kar je verjetno posledica njegovega antagonističnega delovanja na adrenergične receptorje α1.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so učinke oziroma vplive opazili le pri izpostavljenostih, za katere so menili, da so zadosti večje od največje izpostavljenosti zdravilu pri človeku, da jih lahko štejemo za malo pomembne pri klinični uporabi zdravila.
English: If you forget to take Sycrest
Slovenian: Če ste pozabili vzeti zdravilo Sycrest
English: There is no experience with asenapine in patients with severe renal impairment who have a creatinine clearance less than 15 mL/min.
Slovenian: Ni izkušenj z uporabo asenapina pri bolnikih s hudo okvaro ledvic, ki imajo očistek kreatinina manjši od 15 ml/min.
English: Actions at other receptors e.g., 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, and α2-adrenergic receptors, may also contribute to the clinical effects of asenapine.
Slovenian: Tudi delovanje na druge receptorje, npr. 5-HT1A, 5-HT1B, 5HT2C, 5-HT6, 5-HT7, D3 in adrenergične receptorje α2, lahko prispeva h kliničnim učinkom asenapina.
English: Furthermore, prolactin-mediated effects on mammary glands and oestrus cycle disturbances were observed.
Slovenian: Poleg tega so opazili tudi s prolaktinom posredovane učinke na prsne žleze in motnje gonitvenega ciklusa.
English: Asenapine was not genotoxic in a battery of tests.
Slovenian: Asenapin ni bil genotoksičen v skupini več različnih testov.
English: Co-administration of asenapine with known inhibitors, inducers or substrates of these metabolic pathways has been studied in a number of drug-drug interaction studies (see section 4.5).
Slovenian: Sočasno uporabo asenapina z znanimi zaviralci, induktorji ali substrati teh presnovnih poti so proučili v več študijah interakcij med zdravili (glejte poglavje 4.5).
English: To ensure optimal absorption, the Sycrest sublingual tablet should be placed under the tongue and allowed to dissolve completely.
Slovenian: Da bi zagotovil optimalno absorpcijo zdravila, naj bolnik položi podjezično tableto zdravila Sycrest pod jezik in počaka, da se popolnoma raztopi.
English: Following co-administration of dextromethorphan and asenapine in healthy subjects, the ratio of dextrorphan/dextromethorphan (DX/DM) as a marker of CYP2D6 activity was measured.
Slovenian: Po sočasni uporabi dekstrometorfana in asenapina pri zdravih preiskovancih so merili razmerje med dekstrorfanom in dekstrometorfanom (DX/DM) kot kazalec aktivnosti CYP2D6.
English: Asenapine is extensively metabolized.
Slovenian: Asenapin se obsežno presnavlja.
English: The potential effects of inhibitors and an inducer of several of these enzyme pathways on asenapine pharmacokinetics were studied, specifically fluvoxamine (CYP1A2 inhibitor), paroxetine (CYP2D6 inhibitor), imipramine (CYP1A2/2C19/3A4 inhibitor), cimetidine (CYP3A4/2D6/1A2 inhibitor), carbamazepine (CYP3A4/1A2 inducer) and valproate (UGT inhibitor).
Slovenian: Proučevali so možne učinke zaviralcev in enega induktorja večih omenjenih encimskih poti na farmakokinetiko asenapina, in sicer fluvoksamina (zaviralca CYP1A2), paroksetina (zaviralca CYP2D6), imipramina (zaviralca CYP1A2/2C19/3A4), cimetidina (zaviralca CYP3A4/2D6/1A2), karbamazepina (induktorja CYP3A4/1A2) in valproata (zaviralca UGT).
English: How to take Sycrest
Slovenian: Kako jemati zdravilo Sycrest
English: Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulations may worsen hypotension in the setting of Sycrest-induced alpha blockade).
Slovenian: Hipotenzijo in odpoved krvnega obtoka je treba zdraviti z ustreznimi ukrepi, na primer z intravenskim dajanjem tekočin in/ali z uporabo simpatikomimetikov (adrenalina in dopamina se ne sme uporabljati, ker lahko spodbujanje adrenergičnih receptorjev beta poslabša hipotenzijo pri zavori adrenergičnih receptorjev alfa z zdravilom Sycrest).
English: Thus, Sycrest is not recommended in patients with severe hepatic impairment.
Slovenian: Zdravilo Sycrest torej ni priporočljivo za bolnike s hudo okvaro jeter.
English: In the long-term extension trial (50 weeks), a total of 34.8 % of subjects experienced clinically significant weight increase (i.e., ≥ 7 % increase in body weight at endpoint).
Slovenian: V dolgotrajnem podaljšanem preskušanju (50 tednov) je imelo skupno 34,8 % preiskovancev klinično pomembno povečanje telesne mase
English: Clinical drug interaction studies investigating the effects of CYP2D6 inhibition by asenapine showed the following results:
Slovenian: Rezultati kliničnih študij interakcij med zdravili, v katerih so proučevali učinke zaviranja CYP2D6 z asenapinom, so bili naslednji:
English: During combined administration with a single dose of asenapine 5 mg, fluvoxamine 25 mg twice daily resulted in a 29 % increase in asenapine AUC.
Slovenian: Med sočasno uporabo z enkratnim 5 mg odmerkom asenapina je fluvoksamin v odmerku 25 mg dvakrat na dan povzročil 29 % povečanje vrednosti AUC za asenapin.
English: All patients met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for bipolar I disorder, current episode manic (DSM-IV 296.4x), or mixed (DSM-IV 296.6x) and had a Young Mania Rating Scale (Y-MRS) score of ≥ 20 at screening and baseline.
Slovenian: Vsi bolniki so izpolnjevali diagnostične kriterije iz Diagnostičnega in statističnega priročnika duševnih motenj, 4. izdaja (DSM-IV), za bipolarno motnjo I, obstoječo manično epizodo (DSM-IV 296.4x) ali mešano motnjo (DSM-IV 296.6x) ter so imeli v času presejalnega pregleda in na začetku študije na lestvici za oceno stopnje manije po Young-u (Young Mania Rating Scale - YMRS) rezultat ≥ 20.
English: Asenapine has no appreciable affinity for muscarinic cholinergic receptors.
Slovenian: Asenapin nima nobene omembe vredne afinitete do muskarinskih holinergičnih receptorjev.
English: Asenapine may cause sleepiness, sudden drops in blood pressure when you stand up, dizziness and changes in your ability to move and balance, which may lead to falls and, consequently, fractures or other injuries.
Slovenian: Asenapin lahko povzroči zaspanost, nenadne padce krvnega tlaka, ko vstanete, omotico in spremembe v sposobnosti gibanja in ravnotežja, kar lahko povzroči padce in posledično zlome ali druge poškodbe.
English: In the combined short-term and long-term schizophrenia and bipolar mania trials in adults, the mean change in body weight for asenapine was 0.8 kg.
Slovenian: V kombiniranih kratkotrajnih in dolgotrajnih preskušanjih pri odraslih bolnikih s shizofrenijo ali manijo pri bipolarni motnji je bila povprečna vrednost spremembe telesne mase pri uporabi asenapina 0,8 kg.
English: 20 sublingual tablets 60 sublingual tablets 100 sublingual tablets
Slovenian: 20 podjezičnih tablet 60 podjezičnih tablet 100 podjezičnih tablet
English: In this short-term, fixed-dose controlled trial there was no evidence of added benefit with a 10 mg twice daily dose compared to 5 mg twice daily.
Slovenian: V tem kratkotrajnem s fiksnim odmerkom nadzorovanem preskušanju ni bilo dokaza o dodatni prednosti 10-miligramskega odmerka dvakrat na dan v primerjavi s 5-miligramskim odmerkom dvakrat na dan.
English: The safety and efficacy of Sycrest was evaluated in 403 paediatric patients with bipolar I disorder who participated in a single, 3-week, placebo-controlled, double-blind trial, of whom 302 patients received Sycrest at fixed doses ranging from 2.5 mg to 10 mg twice daily.
Slovenian: Varnost in učinkovitost zdravila Sycrest so ovrednotili pri 403 pediatričnih bolnikih z bipolarno motnjo I, ki so sodelovali v enojnem, 3-tedenskem, s placebom nadzorovanem, dvojno slepem preskušanju, v katerem je 302 bolnikov prejemalo zdravilo Sycrest v fiksnih odmerkih od 2,5 mg do 10 mg dvakrat na dan.
English: In adolescents, the 10 mg twice daily dose did not result in increased exposure compared to 5 mg twice daily.
Slovenian: Pri mladostnikih odmerek 10 mg dvakrat na dan ni povzročil povečane izpostavljenosti v primerjavi z odmerkom 5 mg dvakrat na dan.
English: Because of its α1-adrenergic antagonism with potential for inducing orthostatic hypotension (see section 4.4), Sycrest may enhance the effects of certain antihypertensive agents.
Slovenian: Možnost, da bi zdravilo Sycrest vplivalo na druga zdravila Zaradi antagonističnega delovanja zdravila Sycrest na adrenergične receptorje α1 z možnostjo, da bo povzročilo ortostatsko hipotenzijo (glejte poglavje 4.4), lahko to zdravilo okrepi učinke določenih antihipertenzivov.
English: Asenapine is a weak inhibitor of CYP2D6.
Slovenian: Asenapin je šibek zaviralec CYP2D6.
English: You should tell your doctor if you are taking medicines for Parkinson's disease (such as levodopa), as this medicine may make them less effective.
Slovenian: Če jemljete zdravila za Parkinsonovo bolezen (na primer levodopo), morate to povedati zdravniku, ker bodo lahko le-ta zaradi sočasnega jemanja tega zdravila postala manj učinkovita.
English: Sycrest is for sublingual use.
Slovenian: Zdravilo Sycrest je namenjeno podjezični uporabi.
English: Asenapine has anaesthetic properties.
Slovenian: Asenapin ima anestetično delovanje.
English: In rats, embryofoetal toxicity (increased post-implantation loss, decreased foetal weights, and delayed ossification) was observed following oral or intravenous administration during organogenesis or throughout gestation.
Slovenian: Pri podganah so opazili toksičnost za zarodek in plod (povečana izguba zarodka po implantaciji, zmanjšana masa ploda in zapoznela osifikacija) po peroralni in intravenski uporabi zdravila v obdobju organogeneze in ves čas gestacije.
English: You should tell your doctor if you are taking antidepressant medicines (specifically fluvoxamine, paroxetine or fluoxetine), as it may be necessary to change your Sycrest or antidepressant medicine dose.
Slovenian: Če jemljete antidepresive (še posebno fluvoksamin, paroksetin ali fluoksetin), morate to povedati zdravniku, ker bo lahko potrebna prilagoditev odmerka zdravila Sycrest ali odmerka antidepresiva.
English: The following symptoms may occur in newborn babies, of mothers that have used Sycrest in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Slovenian: Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo Sycrest, se lahko pojavijo naslednji simptomi: tresenje, okornost in/ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
English: If a patient develops signs and symptoms indicative of NMS Sycrest must be discontinued.
Slovenian: Če se pri bolniku pojavijo znaki in simptomi, ki kažejo na nastanek NMS, mu je treba zdravilo Sycrest ukiniti.
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Slovenian: Uporaba zdravil, ki delujejo antagonistično na dopaminske receptorje, je bila povezana z nastankom tardivne diskinezije, za katero so značilni ritmični, nehotni gibi, predvsem na jeziku in/ali obrazu.
English: From the short-term (6 weeks) schizophrenia trials there appears to be a dose-response relationship for akathisia in patients treated with asenapine, and for parkinsonism there was an increasing trend with higher doses.
Slovenian: Na podlagi kratkotrajnih (6-tedenskih) preskušanj pri bolnikih s shizofrenijo je videti, da obstaja pri bolnikih, zdravljenih z asenapinom, v primeru akatizije povezanost med odmerkom zdravila in odzivom nanj, v primeru parkinsonizma pa so opazili tendenco okrepitve pri večjih odmerkih.
English: Serious side effects have been reported with this medicine.
Slovenian: Pri uporabi tega zdravila so poročali o resnih neželenih učinkih.
English: If your baby develops any of these symptoms you may need to contact your doctor.
Slovenian: Če pri otroku opazite katerega koli od teh simptomov, se posvetujte z zdravnikom.
English: Sycrest is not approved for the treatment of elderly patients with dementia and is not recommended for use in this particular group of patients.
Slovenian: Zdravilo Sycrest ni bilo odobreno za zdravljenje starostnikov z demenco in ga za uporabo pri tej posebni skupini bolnikov ne priporočamo.
English: Asenapine may cause adverse effects such as somnolence, orthostatic hypotension, dizziness and extrapyramidal symptoms, which may lead to falls and, consequently, fractures or other injuries.
Slovenian: Asenapin lahko povzroči neželene učinke, kot so somnolenca, ortostatska hipotenzija, omotica in ekstrapiramidni simptomi, kar lahko povzroči padce in posledično zlome ali druge poškodbe.
English: During twice-daily dosing, steady-state is attained within 3 days.
Slovenian: Pri jemanju zdravila dvakrat na dan je stanje dinamičnega ravnovesja doseženo v 3 dneh.
English: In a PK study using unflavoured sublingual tablets, at the 5 mg twice daily dose level, asenapine pharmacokinetics in adolescent patients (12 to 17 years of age, inclusive) are similar to those observed in adults.
Slovenian: V farmakokinetični študiji, kjer so uporabili podjezične tablete brez okusa v odmerku 5 mg dvakrat na dan, je bila farmakokinetika asenapina pri bolnikih mladostnikih (starih od vključno 12 let do vključno 17 let ) podobna kot pri odraslih.
English: Illnesses that affect the brain, such as bipolar I disorder, may be due to certain chemicals in the brain, such as dopamine and serotonin, being out of balance and these imbalances may cause some of the symptoms you may be experiencing.
Slovenian: Bolezni, ki prizadenejo možgane in med katere sodi tudi bipolarna motnja I, lahko nastanejo zaradi neravnovesja določenih kemičnih snovi v možganih, kot sta dopamin in serotonin, in to lahko vodi do pojava nekaterih simptomov, ki jih imate morda tudi vi. Ni točno znano, kako deluje to zdravilo, vendar menijo, da nekako popravi ravnovesje teh kemičnih snovi.
English: Newborn infants exposed to antipsychotics (including Sycrest) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Slovenian: Pri novorojenčkih, ki so bili med tretjim trimesečjem nosečnosti izpostavljeni antipsihotikom (vključno z zdravilom Sycrest), obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, katerih jakost in čas trajanja po porodu sta lahko različna.
English: For combination therapy a starting dose of 5 mg twice daily is recommended.
Slovenian: Pri kombinirani terapiji je priporočen začetni odmerek 5 mg dvakrat na dan.
English: A population pharmacokinetic analysis indicated that there is no evidence of gender-related differences in the pharmacokinetics of asenapine.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da ni razlik v farmakokinetiki asenapina med spoloma.
English: Marketing Authorisation Holder N.V. Organon
Slovenian: Imetnik dovoljenja za promet z zdravilom N.V.
English: Sycrest should be used with caution in elderly patients and in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration and hypovolemia).
Slovenian: Zdravilo Sycrest je torej treba uporabljati previdno pri starostnikih in bolnikih z znanimi srčno-žilnimi boleznimi (npr. srčnim popuščanjem, miokardnim infarktom ali ishemijo ter motnjami srčnega prevajanja), možgansko-žilnimi boleznimi ali stanji, ki povečajo nagnjenost bolnika k hipotenziji (npr. dehidracijo in hipovolemijo).
English: Uncommon side effects (may affect up to 1 in 100 people) - abnormal muscle movements: a collection of symptoms known as extrapyramidal symptoms
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - nenormalni mišični gibi; gre za skupino simptomov, ki jim pravimo ekstrapiramidni simptomi
English: Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Slovenian: Pretisni omoti iz dveh aluminijastih folij v škatlah po 20, 60 ali 100 podjezičnih tablet.
English: Gelatin Mannitol (E421)
Slovenian: 6.1 Seznam pomožnih snovi želatina manitol (E421)
English: Paediatric studies with Sycrest were performed using flavoured sublingual tablets.
Slovenian: V pediatričnih študijah z zdravilom Sycrest so uporabljali podjezične tablete z okusom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete,ste pred kratkim jemaliali pa boste morda začeli jematikaterokoli drugo zdravilo.Nekatera zdravila lahko zmanjšajo ali zvečajo delovanje zdravila Sycrest.
English: Falls may occur as a result of one or more adverse events such as the following: Somnolence, Orthostatic hypotension, Dizziness, Extrapyramidal symptoms.
Slovenian: Padci se lahko pojavijo kot posledica enega ali več neželenih učinkov, kot so: somnolenca, ortostatska hipotenzija, omotica, ekstrapiramidni simptomi.
English: Figure 1
Slovenian: slika 1
English: In a dedicated study, concomitant smoking during administration of a single 5 mg sublingual dose had no effect on the pharmacokinetics of asenapine.
Slovenian: Tudi v za to posebej izvedeni študiji kajenje med jemanjem enkratnega podjezičnega 5 mg odmerka ni imelo nobenega vpliva na farmakokinetiko asenapina.
English: Co-administration of a single 20 mg dose of paroxetine (a CYP2D6 substrate and inhibitor) during treatment with 5 mg asenapine twice daily in 15 healthy male subjects resulted in an almost 2-fold increase in paroxetine exposure.
Slovenian: Sočasna uporaba enkratnega 20 mg odmerka paroksetina (substrat in zaviralec CYP2D6) med zdravljenjem s 5 mg asenapina dvakrat na dan pri 15 zdravih moških preiskovancih je vodila do skoraj 2-kratnega povečanja izpostavljenosti paroksetinu.
English: If you stop taking Sycrest
Slovenian: Če ste prenehali jemati zdravilo Sycrest
English: The most frequently reported adverse drug reactions (ADRs) associated with the use of asenapine in clinical trials were somnolence and anxiety.
Slovenian: Najpogosteje poročana neželena učinka, povezana z uporabo asenapina v kliničnih preskušanjih, sta bila somnolenca in tesnoba.
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Slovenian: Med znake povečane občutljivosti bolnika lahko sodijo zmedenost, otopelost, posturalna nestabilnost s pogostimi padci ter tudi ekstrapiramidni simptomi.
English: Following oral administration to pregnant rabbits during the period of organogenesis, asenapine adversely affected body weight at the high dose of 15 mg.kg twice daily.
Slovenian: Po njegovi peroralni uporabi pri brejih samicah kuncev v obdobju organogeneze je imel asenapin neugoden vpliv na telesno maso pri višjem odmerku, to je 15 mg/kg dvakrat na dan.
English: The efficacy of asenapine in the treatment of a DSM-IV manic or mixed episode of bipolar I disorder with or without psychotic features was evaluated in two similarly designed 3-week, randomized, double-blind, flexible-dose, placebo- and active controlled (olanzapine) monotherapy trials involving 488 and 489 patients, respectively.
Slovenian: Učinkovitost asenapina pri zdravljenju manične ali mešane epizode bipolarne motnje I po DSM-IV z ali brez psihotičnih značilnosti so ovrednotili v dveh podobno zasnovanih 3-tedenskih, randomiziranih, dvojno slepih s placebom in zdravilno učinkovino (olanzapin) nadzorovanih preskušanjih monoterapije s prilagodljivim odmerkom pri 488 oziroma 489 bolnikih.
English: Asenapine caused mild maternal toxicity and slight retardation of foetal skeletal development.
Slovenian: Asenapin je povzročil tudi blago toksičnost pri samicah in rahel zastoj v razvoju skeleta pri plodu.
English: What Sycrest contains - The active substance is asenapine.
Slovenian: Kaj vsebuje zdravilo Sycrest - Zdravilna učinkovina je asenapin.
English: Tell your doctor right away if you have: - signs of increased blood sugar levels such as excessive thirst, hunger or urination, weakness or onset of worsening of diabetes - worm-like movements of the tongue, or other uncontrolled movements of the tongue, mouth,
Slovenian: Takoj povejte zdravniku, če imate: - znake zvišane koncentracije krvnega sladkorja, kot so povečana žeja, lakota ali pogostejše uriniranje, šibkost ali pojav poslabšanja sladkorne bolezni - zvijanje jezika ali drugi nekontrolirani gibi jezika, ust, obraza ali čeljusti, ki se lahko razširijo na roke in noge
English: Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Slovenian: Pri bolnikih so pogosto opažali prehodno, asimptomatsko zvišanje vrednosti jetrnih transaminaz, alanin aminotransferaze (ALT) in aspartat aminotransferaze (AST), še posebej na začetku zdravljenja.
English: When asenapine was administered intravenously to pregnant rabbits, no signs of embryotoxicity were observed.
Slovenian: Pri intravenskem dajanju asenapina brejim samicam kuncev niso opazili nobenih znakov embriotoksičnosti.
English: In a population pharmacokinetic analysis, no clinical relevant effects of race on the pharmacokinetics of asenapine were found.
Slovenian: V analizi populacijske farmakokinetike niso ugotovili nobenih klinično pomembnih učinkov rase na farmakokinetiko asenapina.
English: If signs and symptoms of tardive dyskinesia appear in a patient on Sycrest, discontinuation of treatment should be considered.
Slovenian: Če se pri bolniku, ki jemlje zdravilo Sycrest, pojavijo znaki in simptomi tardivne diskinezije, je treba razmisliti o ukinitvi zdravila.
English: Increasing the dose from 5 to 10 mg twice daily (a two-fold increase) results in less than linear (1.7 times) increases in both the extent of exposure and maximum concentration.
Slovenian: dvakratno povečanje) vodi do manj kot linearnega povečanja (1,7-kratnega) tako stopnje izpostavljenosti kot največje koncentracije zdravila.
English: Both asenapine doses (5 mg BID and 10 mg BID) were superior to placebo and showed statistically significant improvement in change from baseline in Y-MRS total score at Day 21 compared with placebo.
Slovenian: Oba odmerka asenapina (5 mg dvakrat na dan in 10 mg dvakrat na dan) sta bila učinkovitejša od placeba in sta v primerjavi s placebom pokazala statistično pomembno izboljšanje skupnega rezultata po lestvici YMRS, merjenega kot spremembo od začetne vrednosti do 21. dneva.