Agid , O , Siu , CO , Potkin , SG , Kapur , S , Watsky , E , Vanderburg , D , Zipursky , RB , Remington , G ( 2013 ). Meta-regression analysis of placebo response in antipsychotic trials, 1970–2010 . American Journal of Psychiatry 170 , 1335 – 1344 .

Alphs , L , Benedetti , F , Flieschhacker , WW , Kane , JM ( 2012 ). Placebo-related effects in clinical trials in schizophrenia: what is driving this phenomenon and what can be done to minimize it? International Journal of Neuropsychopharmacology 15 , 1003 – 1014 .

APA ( 1994 ). Diagnostic and Statistical Manual of Mental Disorders , 4th edn. American Psychiatric Association : Washington, DC .

Barnes , TR ( 1989 ). A rating scale for drug-induced akathisia . British Journal of Psychiatry 154 , 672 – 676 .

Barnes , TRE , Drake , RJ , Dunn , G , Hayhurst , KP , Jones , PB , Lewis , SW ( 2013 ). Effect of prior treatment with antipsychotic long-acting injection on randomised clinical trial treatment outcomes . British Journal of Psychiatry 203 , 215 – 220 .

Begg , C , Cho , M , Eastwood , S , Horton , R , Moher , D , Olkin , I , Pitkin , R , Rennie , D , Schulz , KF , Simel , D , Stroup , DF ( 1996 ). Improving the quality of reporting of randomized controlled trials. The CONSORT statement . Journal of the American Medical Association 276 , 637 – 639 .

Borison , RL , Huff , FJ , Griffiths , I ( 1996 ). Efficacy of 5 mg/day and 8 mg iloperidone administered to schizophrenic patients for 42 days . Psychopharmacology Bulletin 32 , 416 .

Buchanan , RW , Panagides , J , Zhao , J , Phiri , P , den Hollander , W , Ha , X , Kouassi , A , Alphs , L , Schooler , N , Szegedi , A , Cazorla , P ( 2012 ). Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia . Journal of Clinical Psychopharmacology 32 , 36 – 45 .

Canuso , CM , Dirks , B , Carothers , J , Kosik-Gonzalez , C , Bossie , CA , Zhu , Y , Damaraju , CV , Kalali , AH , Mahmoud , R ( 2009 ). Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia . American Journal of Psychiatry 166 , 691 – 701 .

Canuso , CM , Lindenmayer , JP , Kosik-Gonzalez , C , Turkoz , I , Carothers , J , Bossie , CA , Schooler , NR ( 2010 a). A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder . Journal of Clinical Psychiatry 71 , 587 – 598 .

Canuso , CM , Schooler , N , Carothers , J , Turkoz , I , Kosik-Gonzalez , C , Bossie , CA , Walling , D , Lindenmayer , JP ( 2010 b). Paliperidone extended-release in schizoaffective disorder: a randomized, controlled study comparing a flexible dose with placebo in patients treated with and without antidepressants and/or mood stabilizers . Journal of Clinical Psychopharmacology 30 , 487 – 495 .

Chouinard , G , Ross-Chouinard , A , Annable , L , Jones , B ( 1980 ). The extrapyramidal symptom rating scale . Canadian Journal of Neurological Sciences 7 , 233 .

Citrome , L , Litman , RE , Wang , Y , Mokliatchouk , O , Németh , G , Laszlovsky , I , Durgam , S ( 2013 ). Cariprazine efficacy in acute exacerbation of schizophrenia: analysis of PANSS data from a Phase III, international, randomized, double-blind, placebo-controlled trial . Schizophrenia Bulletin 39 , S325 .

ClinicalTrials.gov ( 2012 a). A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia ( a). www.clinicaltrials.gov/ct2/show/NCT00044044?term=NCT00044044&rank=1 ). Accessed , last .

ClinicalTrials.gov ( 2012 b). Lurasidone HCL – A 6-Week Phase 3 Study of Patients With Acute Schizophrenia. (PEARL 3) ( b). www.clinicaltrials.gov/ct2/show/NCT00790192?term=NCT00790192&rank=1 ). Accessed , last .

Cochrane Bias Methods Group ( 2013 ). Assessing risk of bias in included studies ( ). http://bmg.cochrane.org/assessing-risk-bias-included-studies ). Accessed .

Cutler , AJ , Kalali , AH , Weiden , PJ , Hamilton , J , Wolfgang , CD ( 2008 ). Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia . Journal of Clinical Psychopharmacology 28 , S20 – S28 .

Davidson , M , Emsley , R , Kramer , M , Ford , L , Pan , G , Lim , P , Eerdekens , M ( 2007 ). Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study . Schizophrenia Research 93 , 117 – 130 .

Essock , SM , Covell , NH , Davis , SM , Stroup , TS , Rosenheck , RA , Lieberman , JA ( 2006 ). Effectiveness of switching antipsychotic medications . American Journal of Psychiatry 163 , 2090 – 2095 .

Fleischhacker , WW , Gopal , S , Lane , R , Gassmann-Mayer , C , Lim , P , Hough , D , Remerie , B , Eerdekens , M ( 2012 ). A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia . International Journal of Neuropsychopharmacology 15 , 107 – 118 .

Gopal , S , Hough , DW , Xu , H , Lull , JM , Gassmann-Meyer , C , Remmerie , BM , Eerdekens , MH , Brown , DW ( 2010 ). Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study . International Clinical Psychopharmacology 25 , 247 – 256 .

Guy , W (ed.) ( 1976 a). The Clinical Global Impressions (CGI) Scale . In ECDEU Assessment Manual for Psychopharmacology , pp. 218 – 222 . U.S. Department of Health, Education, and Welfare : Rockville, MD .

Guy , W (ed.) ( 1976 b). Abnormal Involuntary Movement Scale (AIMS) . In ECDEU Assessment Manual for Psychopharmacology , pp. 534 – 537 . U.S. Department of Health, Education, and Welfare : Rockville, MD .

Heres , S , Davis , J , Maino , K , Jetzinger , E , Kissling , W , Leucht , S ( 2006 ). Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head studies of second-generation antipsychotics . American Journal of Psychiatry 163 , 185 – 194 .

Hough , D , Gopal , S , Vijapurkar , U , Lim , P , Morozova , M , Eerdekens , M ( 2009 ). Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study . Schizophrenia Research 116 , 107 – 117 .

Ioannidis , JP , Evans , SJ , Gøtzsche , PC , O'Neill , RT , Altman , DG , Schulz , K , Moher , D ; CONSORT Group ( 2004 ). Better reporting of harms in randomized trials: an extension of the CONSORT statement . Annals of Internal Medicine 141 , 781 – 788 .

Isaac , M , Koch , A ( 2010 ). The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia . European Neuropsychopharmacology 20 , 139 – 145 .

Johnson , E , Jørgensen , HA ( 2008 ). Effectiveness of second-generation antipsychotics: a systematic review of randomised trials . BMC Psychiatry 8 , 31 – 44 .

Jones , PB , Barnes , TRE , Davies , L , Dunn , G , Lloyd , H , Hayhurst , KP , Murray , RM , Markwick , A , Lewis , SW ( 2006 ). Randomized controlled trial of the effect on quality of life of second- vs first-generation antipsychotic drugs in schizophrenia: Cost Utility of the Latest Antisychotic Drugs in Schizophrenia Study (CUtLASS) . Archives of General Psychiatry 63 , 1079 – 1087 .

Kane , J , Canas , F , Kramer , M , Ford , L , Gassmann-Mayer , C , Lim , P , Eerdekens , M ( 2007 ). Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial . Schizophrenia Research 90 , 147 – 161 .

Kane , JM , Cohen , M , Zhao , J , Alphs , L , Panagides , J ( 2010 a). Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia . Journal of Clinical Psychopharmacology 30 , 106 – 115 .

Kane , JM , Detke , HC , Naber , D , Sethuraman , G , Lin , DY , Bergstrom , RF , McDonnell , D ( 2010 b). Olanzapine long-acting injection: a 24-week, randomised, double-blind trial of maintenance treatment in patients with schizophrenia . American Journal of Psychiatry 167 , 181 – 189 .

Kane , JM , Laurellio , J , Laska , E , Di Marino , M , Wolfgang , CD ( 2008 ). Long-term efficacy and safety of iloperidone: results from 3 clinical trials for the treatment of schizophrenia . Journal of Clinical Psychopharmacology 28 , S29 – S35 .

Kane , JM , Mackle , M , Snow-Adami , L , Zhao , J , Szegedi , A , Panagides , J ( 2011 ). A randomised placebo-controlled trial of asenapine for the prevention of relapse for schizophrenia after long-term treatment . Journal of Clinical Psychiatry 72 , 349 – 355 .

Kay , SR , Fiszbein , A , Opler , LA ( 1987 ). The positive and negative syndrome scale (PANSS) for schizophrenia . Schizophrenia Bulletin 13 , 261 – 276 .

Kinon , B , Millen , BA , Downing , AC , Zhang , L , Stauffer , VL , Anderson , SW , Gomex , JC ( 2013 ). LY2140023 monohydrate in the treatment of patients with schizophrenia: results of 2 clinical trials assessing efficacy in treating acutely ill patients and those with prominent negative symptoms . Schizophrenia Bulletin 39 , S338 .

Kinon , BJ , Zhang , L , Millen , BA , Osuntokun , OO , Williams , JE , Kollack-Walker , S , Jackson , K , Kryzhanovskaya , L , Jarkova , N ( 2011 ). A multicenter, inpatient, phase 2, double-blind, placebo-controlled dose-ranging study of LY2140023 monohydrate in patients with DSM-IV schizophrenia . Journal of Clinical Psychopharmacology 31 , 349 – 355 .

Kramer , M , Litman , R , Hough , D , Lane , R , Lim , P , Liu , Y , Eerdekens , M ( 2010 ). Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study . International Journal of Neuropsychopharmacology 13 , 635 – 647 .

Kramer , M , Simpson , G , Maciulis , V , Kushner , S , Vijapurkar , U , Lim , P , Eerdekens , M ( 2007 ). Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study . Journal of Clinical Psychopharmacology 27 , 6 – 14 .

Lane , P ( 2008 ). Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches . Pharmaceutical Statistics 7 , 93 – 106 .

Lauriello , J , Lambert , T , Andersen , S , Lin , D , Taylor , CC , McDonnell , D ( 2008 ). An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia . Journal of Clinical Psychiatry 69 , 790 – 799 .

Leucht , S , Cipriani , A , Spineli , L , Mavridis , D , Örey , D , Richer , F , Samara , M , Barbui , C , Engel , RR , Geddes , JR , Kissling , W , Stapf , MP , Lässig , B , Salanti , G , Davis , JM ( 2013 ). Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis . Lancet 382 , 951 – 962 .

Leucht , S , Corves , C , Arbter , D , Engel , RR , Li , C , Davis , JM ( 2009 a). Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis . Lancet 373 , 31 – 41 .

Leucht , S , Kissling , W , Davis , JM ( 2009 b). Second-generation antipsychotics for schizophrenia: can we resolve the conflict? Psychological Medicine 39 , 1591 – 1602 .

Li , H , Rui , Q , Ning , X , Xu , H , Gu , N ( 2011 ). A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia . Progress in Neuro-Psychopharmacology and Biological Psychiatry 35 , 1002 – 1008 .

Lieberman , JA , Stroup , TS , McEvoy , JP , Swartz , MS , Rosenheck , RA , Perkins , DO , Keefe , RSE , Davis , SM , Davis , CE , Lebowitz , BD , Severe , J , Hsiao , JK ( 2005 ). Effectiveness of antipsychotic drugs in patients with chronic schizophrenia . New England Journal of Medicine 353 , 1209 – 1223 .

Loebel , A , Cucchiaro , J , Sarma , K , Xu , L , Hsu , C , Kalali , AH , Pikalov , A , Potkin , SG ( 2013 ). Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial . Schizophrenia Research 145 , 101 – 109 .

Marder , SR , Kramer , M , Ford , L , Eerdekens , E , Lim , P , Eerdekens , M , Lowy , A ( 2007 ). Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study . Biological Psychiatry 62 , 1363 – 1370 .

Meltzer , HY , Bobo , WV , Nuamah , IF , Lane , R , Hough , D , Kramer , M , Eerdekens , M ( 2008 ). Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies . Journal of Clinical Psychiatry 69 , 817 – 829 .

Meltzer , HY , Cucchiaro , J , Silva , R , Ogasa , M , Phillips , D , Xu , J , Kalali , AH , Scweizer , E , Pikalov , A , Loebel , A ( 2011 ). Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study . American Journal of Psychiatry 168 , 957 – 967 .

Moher , D , Schultz , KF , Altman , DG ( 2001 ). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials . Lancet 357 , 1191 – 1194 .

Nakamura , M , Ogasa , M , Guarino , J , Phillips , D , Severs , J , Cucchiaro , J , Loebel , A ( 2009 ). Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial . Journal of Clinical Psychiatry 70 , 829 – 836 .

Nasrallah , HA , Gopal , S , Gassmann-Meyer , C , Quiroz , JA , Lim , P , Eerdekens , M , Yuen , E , Hough , D ( 2010 ). A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia . Neuropsychopharmacology 35 , 2072 – 2082 .

Pandina , G , Lane , R , Gopal , S , Gassmann-Mayer , C , Hough , D , Remmerie , B , Simpson , G ( 2011 ). A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia . Progress in Neuro-Psychopharmacology and Biological Psychiatry 35 , 218 – 226 .

Pandina , GJ , Lindenmayer , JP , Lull , J , Lim , P , Gopal , S , Herben , V , Kusumakar , V , Yuen , E , Palumbo , J ( 2010 ). A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia . Journal of Clinical Psychopharmacology 30 , 235 – 244 .

Patel , MX , Arista , IA , Taylor , M , Barnes , TRE ( 2013 ). How to compare doses of different antipsychotics: a systematic review of methods . Schizophrenia Research 149 , 141 – 148 .

Patil , ST , Zhang , L , Martenyi , F , Lowe , SL , Jackson , KA , Andreev , BV , Avedisova , AS , Bardenstein , LM , Gurovich , IY , Morozova , MA , Mosolov , SN , Neznanov , NG , Reznik , AM , Smulevich , AB , Tochilov , VA , Johnson , BG , Monn , JA , Schoepp , DD ( 2007 ). Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial . Nature Medicine 13 , 1102 – 1107 .

Piaggio , G , Elbourne , DR , Altman , DG , Pocock , SJ , Evans , JW ( 2006 ). Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement . Journal of the American Medical Association 295 , 1152 – 1160 .

Piaggio , G , Elbourne , D , Altman , DG , Pocock , SJ , Evans , SJW ; CONSORT Group ( 2012 ). Reporting of non-inferiority and equivalence randomized trials: an extension of the CONSORT statement . Journal of the American Medical Association 308 , 2594 – 2604 .

Pope , A , Adams , C , Paton , C , Weaver , T , Barnes , TRE ( 2010 ). Assessment of adverse effects in clinical studies of antipsychotic medication: surveys of methods used . British Journal of Psychiatry 197 , 67 – 72 .

Potkin , SG , Cohen , MD , Panagides , J ( 2007 ). Efficacy and tolerability of asenapine in acute schizophrenia: a placebo- and risperidone-controlled trial . Journal of Clinical Psychiatry 68 , 1492 – 1500 .

Potkin , SG , Litman , RE , Torres , R , Wolfgang , CD ( 2008 ). Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies . Journal of Clinical Psychopharmacology 28 , S4 – S11 .

Rabinowitz , J , Werbeloff , N , Caers , I , Mandel , FS , Jaeger , J , Stauffer , V , Menard , F , Kinon , B , Kapur , S ( 2014 ). Combining efficacy and completion rates with no data imputation: a composite approach with greater sensitivity for the statistical evaluation of active comparisons in antipsychotic trials . European Neuropsychopharmacology 24 , 357 – 368 .

Rabinowitz , J , Werbeloff , N , Caers , I , Mandel , FS , Stauffer , V , Menard , F , Kinon , B , Kapur , S ( 2013 ). Negative symptoms in schizophrenia – the remarkable impact of inclusion definitions in clinical trials and their consequences . Schizophrenia Research 150 , 334 – 338 .

Schoemaker , J , Naber , D , Vrijland , P , Panagides , J , Emsley , R ( 2010 ). Long-term assessment of asenapine vs. olanzapine in patients with schizophrenia or schizoaffective disorder . Pharmacopsychiatry 43 , 138 – 146 .

Schulz , KF , Altman , DG , Moher , D ( 2010 ). CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials . British Medical Journal 340 , 698 – 702 .

Siddiqui , O , Hung , HM , O'Neill , R ( 2009 ). MMRM vs LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets . Journal of Biopharmaceutical Statistics 19 , 227 – 246 .

Simpson , GM , Angus , JW ( 1970 ). A rating scale for extrapyramidal side effects . Acta Psychiatrica Scandinavica 212 , S11 – S19 .

Umbricht , D , Martin-Facklam , M , Youssef , E , Yoo , K , Dorflinger , E , Bausch , A , Alberati , D , Santarelli , L ( 2011 ). Glycine reuptake inhibitor RG1678: results of the proof-of-concept study for the treatment of negative symptoms in schizophrenia . European Neuropsychopharmacology 21 , S517 – S518 .

Vickers , AJ , Altman , DG ( 2001 ). Analysing controlled trials with baseline and follow up measurements . British Medical Journal 323 , 1123 – 1124 .