TY - JOUR
T1 - 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
AU - Ishigooka, Jun
AU - Nakagome, Kazuyuki
AU - Ohmori, Tetsuro
AU - Iwata, Nakao
N1 - Funding Information:
This study is supported by a research grant from The Waksman Foundation of Japan, Inc.
Funding Information:
JI, TO and NI received research funding, grant, honoraria from Otsuka Pharmaceutical Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd. and Janssen Pharmaceutical KK. KN received honoraria from Otsuka Pharmaceutical Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd and Janssen Pharmaceutical KK. All authors have advisory role for Otsuka Pharmaceutical Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd and Janssen Pharmaceutical KK.
PY - 2013/10/3
Y1 - 2013/10/3
N2 - 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 Registry 000007942.
AB - 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 Registry 000007942.
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U2 - 10.1186/1471-244X-13-243
DO - 10.1186/1471-244X-13-243
M3 - Article
C2 - 24090047
AN - SCOPUS:84884829766
SN - 1471-244X
VL - 13
JO - BMC Psychiatry
JF - BMC Psychiatry
M1 - 243
ER -