***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) . METHOD Adults experiencing an acute psychotic episode were r and omized to 12 weeks of double-blind treatment with  AOM 400 mg or placebo ( October 2012-August 2013 ) . The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score . The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score . Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores . The study took place from October 2012 through August 2013 . RESULTS Patients ( N = 340 ; 79 % male , 66 % black ) were r and omized to AOM ( n = 168 ) or placebo ( n = 172 ) . Least squares ( LS ) mean change from baseline to endpoint ( week 10 ) favored AOM versus placebo in PANSS total ( treatment difference , -15.1 [ 95 % CI , -19.4 to -10.8 ] ; P < .0001 ) and CGI-S ( treatment difference , -0.8 [ 95 % CI , -1.1 to -0.6 ] ; P < .0001 ) scores , as it did at all other timepoints through 12 weeks ( all P ≤ .0005 ) . LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < .0001 ) . Common ( > 10 % ) treatment-emergent adverse events  ( AOM vs. placebo ) were increased weight ( 16.8 % vs 7.0 % ) , headache ( 14.4 % vs. 16.3 % ) , and akathisia ( 11.4 % vs 3.5 % ) . CONCLUSIONS Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability . These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01663532 OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate Paliperidone palmitate is a long-acting injectable antipsychotic agent . This 13-week , multicenter , r and omized ( 1 : 1 : 1 : 1 ) , double-blind , parallel-group study evaluated the efficacy , safety , and tolerability of fixed 25 , 50 , and 100 milligram equivalent ( mg equiv . ) doses of paliperidone palmitate vs placebo administered as gluteal injections on days 1 and 8 , then every 4 weeks ( days 36 and 64 ) in 518 adult patients with schizophrenia . The intent-to-treat analysis set ( N=514 ) was 67 % men and 67 % White , with a mean age of 41 years . All paliperidone palmitate dose groups showed significant improvement vs placebo in the Positive and Negative Syndrome Scale ( PANSS ) total score ( primary efficacy measure ; 25 and 50 mg equiv . , p=0.02 ; 100 mg equiv . , p<0.001 ) , as well as Clinical Global Impression Severity scores ( p⩽0.006 ) and PANSS negative and positive symptom Marder factor scores ( p⩽0.04 ) . The Personal and Social Performance scale showed no significant difference between treatment groups . The overall incidence of treatment-emergent adverse events was similar between groups . Parkinsonism , the most frequently reported extrapyramidal symptom , was reported at similar rates for placebo ( 5 % ) and paliperidone palmitate ( 5–6 % across doses ) . The mean body mass index and mean weight showed relatively small dose-related increases during paliperidone palmitate treatment . Investigator-evaluated injection-site pain , swelling , redness , and in duration were similar across treatment groups ; scores for patient-evaluated injection-site pain ( visual analog scale ) were similar across groups and diminished with time . All doses of once-monthly paliperidone palmitate were efficacious and generally tolerated , both locally and systemically . Paliperidone palmitate offers the potential to improve outcomes in adults with symptomatic schizophrenia OBJECTIVE To directly compare aripiprazole once-monthly 400 mg ( AOM 400 ) and paliperidone palmitate once-monthly ( PP ) on the Heinrichs-Carpenter Quality -of-Life Scale ( QLS ) , a vali date d health-related quality of life and functioning measure in schizophrenia . METHOD This 28-week , r and omized , non-inferiority , open-label , rater-blinded , head-to-head study ( QUALIFY ) of AOM 400 and PP in adult patients ( 18 - 60 years ) comprised oral conversion , initiation of AOM 400 or PP treatment , and continuation with intramuscular injections every 4weeks . The primary endpoint assessed non-inferiority and superiority on QLS total score analyzed using a mixed model for repeated measurements . RESULTS Of 295 r and omized patients , 100/148 ( 67.6 % ) of AOM 400 and 83/147 ( 56.5 % ) of PP patients completed 28weeks of treatment . A statistically significant least squares mean difference in change from baseline to week 28 on QLS total score ( 4.67 [ 95%CI : 0.32;9.02 ] , p=0.036 ) confirmed non-inferiority and established superiority of AOM 400 vs PP . There were also significant improvements in Clinical Global Impression - Severity scale and the Investigator 's Assessment Question naire for AOM 400 vs PP , and pre-defined sub-group analyses revealed a consistent pattern of significance favoring AOM 400 in patients ≤35years . Common treatment-emergent adverse events in the treatment continuation phase were more frequent with PP vs AOM 400 , and adverse events were the most frequent reason for discontinuation ( 27/137 [ 19.7 % ] for PP and 16/144 [ 11.1 % ] for AOM 400 ) . All-cause discontinuation was numerically lower with AOM 400 . CONCLUSION Superior improvements on clinician-rated health-related quality of life and a favorable tolerability profile suggest greater overall effectiveness for aripiprazole once-monthly vs paliperidone palmitate . Clinical Trials.gov identifier : NCT01795547 Recognition of prodromal symptoms of schizophrenia offers the potential of early intervention to avert relapse and re-hospitalization ( Carpenter & Heinrichs , 1983 ) . The present study investigated how a strategy to detect prodromal signs might be effectively applied in the clinical setting . A st and ard monitoring system was developed involving completion of a new early signs scale ( ESS ) measuring changes in key symptoms phenomenologically ( self-report ) and behaviourally ( observer report ) . The ESS was subject to rigorous psychometric evaluation and tested in a prospect i ve pilot investigation . The ESS reliably identified early signs and predicted relapse with an overall accuracy of 79 % . Several different patterns of relapse were identified . Observer reports compensated for loss of insight in some patients . In two cases where early signs indices were detected , prompt increases in medication appeared to arrest relapse and avert readmission . The ESS offers itself as a reliable , valid and administratively feasible measure and demonstrates considerable potential as a cost-effective procedure for secondary prevention Background This 13-week , double-blind study was conducted to confirm the efficacy and safety of paliperidone palmitate ( PP ) , at dosing regimens approved in other countries , in Asian patients with schizophrenia . Methods Asian patients ( aged ≥20 years ) diagnosed with schizophrenia ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition-Text Revision criteria ) , and having a Positive and Negative Syndrome Scale ( PANSS ) total score of 60 to 120 were enrolled and r and omized ( 1:1 ) to a  PP or placebo group . Patients received PP intramuscularly at recommended doses : initiation dose 150 mg equivalent ( eq ) PP on day 1 and 100 mg eq PP on day 8 ( deltoid ) ; and a monthly maintenance dose of 75 mg eq PP on days 36 and 64 ( deltoid or gluteal ) . The change from baseline to week 13 in PANSS total scores ( primary endpoint ) , Clinical Global Impression-Severity ( CGI-S ) scores , and PANSS Marder factor scores and subscales , and responder rate at week 13 were evaluated . Safety was also assessed . Results The PANSS total score ( P<0.0001 , least-squares mean change from baseline to week 13 : PP , −3.5 ; placebo , + 6.2 ) , CGI-S score ( P<0.0001 ) , and PANSS Marder factor scores ( P≤0.0025 ) were significantly improved at week 13 in the PP group versus placebo . More treatment responders ( ≥30 % decrease in PANSS total score ) were in the PP group ( 22.8 % ) versus placebo ( 8.5 % ) . Insomnia ( PP 17.0 % versus placebo 15.2 % ) , injection site pain ( 13.2 % versus 6.7 % ) , nasopharyngitis ( 12.6 % versus 6.1 % ) , psychiatric symptoms ( 11.3 % versus 26.2 % ) , and extrapyramidal symptoms ( 10.1 % versus 4.9 % ) were the most frequently occurring treatment-emergent adverse events . Conclusion PP is efficacious for Asian patients with schizophrenia at the dosing regimen approved in other countries , with a similar safety and tolerability profile Background This post hoc analysis ( trial registration : Clinical Trials.gov NCT00590577 ) assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate ( PP ) , a long-acting atypical antipsychotic initiated by day 1 and day 8 injections , in a markedly to severely ill schizophrenia population . Methods Subjects entering the 13-week , double-blind trial were r and omized to PP ( 39 , 156 , or 234 mg [ 25 , 100 , and 150 mg eq of paliperidone  , respectively ] ) or placebo . This subgroup analysis included those with a baseline Clinical Global Impressions-Severity ( CGI-S ) score indicating marked to severe illness . PP subjects received a 234-mg day 1 injection ( deltoid ) , followed by their assigned dose on day 8 and monthly thereafter ( deltoid or gluteal ) . Thus , data for PP groups were pooled for days 4 and 8 . Measures included Positive and Negative Syndrome Scale ( PANSS ) , CGI-S , Personal and Social Performance ( PSP ) , and adverse events ( AEs ) . Analysis of covariance ( ANCOVA ) and last-observation-carried-forward ( LOCF ) method ologies , without multiplicity adjustments , were used to assess changes in continuous measures . Onset of efficacy was 
    Output:
    
Within the context of the inherent limitations of the current analysis , our results may suggest that there may be relative advantages for AOM over PP in the short-term treatment of schizophrenia