The quality of reporting of phase II and III trials for new antipsychotics: A systematic review

Psychological Medicine

Volumn 45, Issue 3, 2015, Pages 467-479

  Patel, M X ^a   Collins, S ^a   Hellier, J ^a   Bhatia, G ^a   Murray, R M ^a  

^a KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

Antipsychotic agents; clinical trials; CONSORT; methodology; schizophrenia; systematic review

Indexed keywords

NEUROLEPTIC AGENT;

CLASSIFICATION; CLINICAL TRIAL (TOPIC); HUMAN; METHODOLOGY; SCHIZOPHRENIA; STANDARDS;

ANTIPSYCHOTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; RESEARCH DESIGN; SCHIZOPHRENIA;

EID: 84927690936     PISSN: 00332917     EISSN: 14698978     Source Type: Journal    
DOI: 10.1017/S0033291714001214     Document Type: Article

References (71)

1. 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.
2. 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.
3. APA (1994). Diagnostic and Statistical Manual of Mental Disorders, 4th edn. American Psychiatric Association: Washington, DC.
4. Barnes TR (1989). A rating scale for drug-induced akathisia. British Journal of Psychiatry 154, 672-676.
5. 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.
6. 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.
7. Borison RL, Huff FJ, Griffiths I (1996). Efficacy of 5 mg/day and 8mg iloperidone administered to schizophrenic patients for 42 days. Psychopharmacology Bulletin 32, 416.
8. 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.
9. 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.
10. Canuso CM, Lindenmayer JP, Kosik-Gonzalez C, Turkoz I, Carothers J, Bossie CA, Schooler NR (2010a). 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.
11. Canuso CM, Schooler N, Carothers J, Turkoz I, Kosik-Gonzalez C, Bossie CA, Walling D, Lindenmayer JP (2010b). 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.
12. Chouinard G, Ross-Chouinard A, Annable L, Jones B (1980). The extrapyramidal symptom rating scale. Canadian Journal of Neurological Sciences 7, 233.
13. 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.
14. ClinicalTrials.gov (2012a). A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia (www.clinicaltrials.gov/ct2/show/NCT00044044? term=NCT00044044&rank=1). Accessed first 27 March 2012, last 28 January 2014.
15. ClinicalTrials.gov (2012b). Lurasidone HCL - A 6-Week Phase 3 Study of Patients With Acute Schizophrenia. (PEARL 3) (www.clinicaltrials.gov/ct2/show/NCT00790192? term=NCT00790192&rank=1). Accessed first 27 March 2012, last 28 January 2014.
16. Cochrane Bias Methods Group (2013). Assessing risk of bias in included studies (http://bmg.cochrane.org/assessingrisk-bias-included-studies). Accessed 2 December 2013.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. Guy W (ed.) (1976a). 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.
23. Guy W (ed.) (1976b). Abnormal Involuntary Movement Scale (AIMS). In ECDEU Assessment Manual for Psychopharmacology, pp. 534-537. U.S. Department of Health, Education, and Welfare: Rockville, MD.
24. 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.
25. 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.
26. 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.
27. Isaac M, Koch A (2010). The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia. European Neuropsychopharmacology 20, 139-145.
28. Johnson E, Jørgensen HA (2008). Effectiveness of second-generation antipsychotics: a systematic review of randomised trials. BMC Psychiatry 8, 31-44.
29. 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.
30. 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.
31. Kane JM, Cohen M, Zhao J, Alphs L, Panagides J (2010a). Efficacy and safety of asenapine in a placeboand haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. Journal of Clinical Psychopharmacology 30, 106-115.
32. Kane JM, Detke HC, Naber D, Sethuraman G, Lin DY, Bergstrom RF, McDonnell D (2010b). 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.
33. 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.
34. 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.
35. Kay SR, Fiszbein A, Opler LA (1987). The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bulletin 13, 261-276.
36. 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.
37. 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.
38. 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.
39. 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.
40. Lane P (2008). Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches. Pharmaceutical Statistics 7, 93-106.
41. 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.
42. 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.
43. Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM (2009a). Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 373, 31-41.
44. Leucht S, Kissling W, Davis JM (2009b). Second-generation antipsychotics for schizophrenia: can we resolve the conflict? Psychological Medicine 39, 1591-1602.
45. 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.
46. 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.
47. 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, placeboand active-controlled trial. Schizophrenia Research 145, 101-109.
48. 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.
49. 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.
50. 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 olanzapinecontrolled study. American Journal of Psychiatry 168, 957-967.
51. 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.
52. 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.
53. 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.
54. 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.
55. 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.
56. 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.
57. 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.
58. 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.
59. 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.
60. 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.
61. 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.
62. 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.
63. 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.
64. 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.
65. 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.
66. Schulz KF, Altman DG, Moher D (2010). CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. British Medical Journal 340, 698-702.
67. 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.
68. Simpson GM, Angus JW (1970). A rating scale for extrapyramidal side effects. Acta Psychiatrica Scandinavica 212, S11-S19.
69. 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.
70. Vickers AJ, Altman DG (2001). Analysing controlled trials with baseline and follow up measurements. British Medical Journal 323, 1123-1124.
71. Weiden PJ, Cutler AJ, Polymeropoulos MH, Wolfgang CD (2008). Safety profile of iloperidone: a pooled analysis of 6-week acute-phase pivotal trials. Journal of Clinical Psychopharmacology 28, S12-S19.