Japan useful medication program for schizophrenia (JUMPs)-long-term study on discontinuation rate, resolution and remission, and improvement in social functioning rate associated with atypical antipsychotic medications in patients with schizophrenia

BMC Psychiatry

Nakao Iwata³  Tetsuro Ohmori⁴  Kazuyuki Nakagome²  Jun Ishigooka¹ 

[1] Department of Psychiatry, Tokyo Women’s Medical University, School of Medicine, Shinjuku-ku, Tokyo, Japan;Translational Medical Center, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan;Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan;Department of Psychiatry, The University of Tokushima Graduate School, Tokushima, Japan

关键词: Paliperidone;    Blonanserin;    Aripiprazole;    Effectiveness study;    Schizophrenia;   

Others  :  1123950
DOI  :  10.1186/1471-244X-13-243

 received in 2013-01-17, accepted in 2013-09-17,  发布年份 2013

【 摘 要 】

Background

It is desirable to establish evidence for the selection of antipsychotics from the viewpoint of recovery of social activity in individual patient with schizophrenia receiving medication. From this perspective, awareness of the importance of studies about drug effectiveness on treatment discontinuation rate, remission rate, and improvement in QOL has grown recently. In Western countries, numerous reports are available in effectiveness studies, which are related to olanzapine and risperidone primarily, whereas evidence for other second-generation antipsychotics (SGAs) is poor. In Japan, no effectiveness study has been reported: thus, it is desirable to collect data that will serve as evidence for selection of the 3 SGAs approved after olanzapine.

Methods

The present study was a long-term effectiveness study under healthcare setting in Japan. It was designed as an open-label, multicenter, randomized, comparative study involving 104-week oral treatment with 1 of the 3 drugs (aripiprazole, blonanserin, and paliperidone) in patients with schizophrenia aged 20 years or over who required antipsychotic medication or switching of the current medication to others for reasons such as lack of efficacy and intolerability. The primary endpoint is treatment discontinuation rate for any causes. The secondary endpoints include remission rate, improvement of social activity, alleviation, aggravation or recurrence of psychiatric symptoms, and safety. The target number of subjects was set at 300.

Discussion

Because this study is expected to yield evidence regarding the selection of antipsychotics for facilitating the recovery of social activity in patients with schizophrenia, it is considered highly valuable to perform this effectiveness study under ordinary healthcare setting in Japan.

Trial registration

UMIN Clinical Trials Registry000007942

【 授权许可】

   
2013 Ishigooka et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Depp C, Lebowitz BD: Clinical trials: bridging the gap between efficacy and effectiveness. Int Rev Psychiatry 2007, 19:531-539.
• [2]Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, et al.: Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005, 353:1209-1223.
• [3]Novick D, Haro JM, Suarez D, Vieta E, et al.: Recovery in the outpatient setting: 36-month results from the Schizophrenia Outpatients Health Outcomes (SOHO) study. Schizophr Res 2009, 108:223-230.
• [4]Appelbaum PS, Grisso T: MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Sarasota, FL: Professional Resource Press; 2001.
• [5]Andreasen NC, Carpenter WT Jr, Kane JM, Lasser RA, et al.: Remission in schizophrenia: proposed criteria and rationale for consensus. Am J Psychiatry 2005, 162:441-449.
• [6]Inada T: DIEPSS: A second-generation rating scale for antipsychotic-induced extrapyramidal symptoms: Drug-induced Extrapyramidal Symptoms Scale. Tokyo, Japan: Seiwa Shoten Publishers, Inc.; 2009.
• [7]Jones PB, Barnes TR, Davies L, Dunn G, et al.: Randomized controlled trial of the effect on Quality of Life of second- vs first-generation antipsychotic drugs in schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1). Arch Gen Psychiatry 2006, 63:1079-1087.
• [8]McEvoy JP, Lieberman JA, Stroup TS, et al.: Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry 2006, 163:600-610.
• [9]Kahn RS, Fleischhacker WW, Boter H, Davidson M, et al.: Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet 2008, 371:1085-1097.
• [10]Burris KD, Molski TF, Xu C, Ryan E, et al.: Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther 2002, 302:381-389.
• [11]Stip E, Tourjman V: Aripiprazole in schizophrenia and schizoaffectivedisorder: a review. Clin Ther 2010, 32(Suppl):3-20.
• [12]Deeks ED, Keating GM: Blonanserin: a review of its use in the management of schizophrenia. CNS Drugs 2010, 24:65-84.
• [13]Gray JA, Roth BL: The pipeline and future of drug development in schizophrenia. Mol Psychiatry 2007, 12:904-922.
• [14]Conley R, Gupta SK, Sathyan G: Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Res Opin 2006, 22:1879-1892.
• [15]Chwieduk CM, Keating GM: Paliperidone extended release: a review of its use in the management of schizophrenia. Drugs 2010, 70:1295-1317.
• [16]Boom S, Thyssen A, Crauwels H, Molz KH, et al.: The influence of hepatic impairment on the pharmacokinetics of paliperidone. Int J Clin Pharmacol Ther 2009, 47:606-616.
• [17]Kane JM, Carson WH, Saha AR, McQuade RD, et al.: Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry 2002, 63:763-771.
• [18]Potkin SG, Saha AR, Kujawa MJ, Carson WH, et al.: Aripiprazole, an antipsychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry 2003, 60:681-690.
• [19]Garcia E, Robert M, Peris F, Nakamura H, et al.: The efficacy and safety of blonanserin compared with haloperidol in acute-phase schizophrenia: a randomized, double-blind, placebo-controlled, multicentre study. CNS Drugs 2009, 23:615-625.
• [20]Yang J, Bahk WM, Cho HS, Jeon YW, et al.: Efficacy and tolerability of Blonanserin in the patients with schizophrenia: a randomized, double-blind, risperidone-compared trial. Clin Neuropharmacol 2010, 33:169-175.
• [21]Davidson M, Emsley R, Kramer M, Ford L, et al.: Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res 2007, 93:117-130.
• [22]Kane J, Canas F, Kramer M, Ford L, et al.: Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res 2007, 90:147-161.
• [23]McIntyre RS, Fallu A, Konarski JZ: Measurable outcomes in psychiatric disorders: remission as a marker of wellness. Clin Ther 2006, 28:1882-1891.
• [24]Thomas P: The stable patient with schizophrenia–from antipsychotic effectiveness to adherence. Eur Neuropsychopharmacol 2007, 17(Suppl 2):S115-S122.
• [25]Gleeson JF, Alvarez-Jimenez M, Cotton SM, et al.: A systematic review of relapse measurement in randomized controlled trials of relapse prevention in first-episode psychosis. Schizophr Res 2010, 119:79-88.
• [26]Essock SM, Schooler NR, Stroup TS, McEvoy JP, et al.: Effectiveness of switching from antipsychotic polypharmacy to monotherapy. Am J Psychiatry 2011, 168:702-708.