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

Study Protocol

Nakao Iwata¹  Tetsuro Ohmori²  Jun Ishigooka³  Kazuyuki Nakagome⁴ 

[1] Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan;Department of Psychiatry, The University of Tokushima Graduate School, Tokushima, Japan;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;

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

DOI  :  10.1186/1471-244X-13-243

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

来源: Springer

【 摘 要 】

BackgroundIt 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.MethodsThe 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.DiscussionBecause 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 registrationUMIN Clinical Trials Registry 000007942

【 授权许可】

CC BY   
© Ishigooka et al.; licensee BioMed Central Ltd. 2013