Abstract:
BACKGROUND:Pharmaceutical companies conduct clinical trials to show the efficacy and safety of new medications for the treatment of schizophrenia. After the new medications are marketed, clinicians treating patients with schizophrenia discover that a considerable number of patients do not respond to these new medications. The goals of the review are to examine the methodology and design of recent antipsychotic clinical trials, identify common flaws, and propose guidelines to fix the flaws and improve the quality of future clinical trials of antipsychotic medications. METHODS:A review of recent antipsychotic clinical trials was conducted using a PubMed search. Ten recent trials published in the past four years were reviewed and their methods analyzed and critiqued. RESULTS:The authors identified six major methodological flaws that may explain the suboptimal response in many patients after a drug is approved. Most of the flaws are related to eligibility criteria, the misuse of the Positive and Negative Syndromes Scale (PANSS) and the lack of consensus on how to define remission, response and exacerbation in schizophrenia. Proposed guidelines for a more rigorous use of the PANSS are presented and recommendations are proposed for using uniform criteria for remission, response and exacerbation in schizophrenia. CONCLUSIONS:The authors recommend using standardized diagnostic interviews to screen patients for eligibility criteria and using the PANSS according to the author's recommendations and the proposed guidelines. Uniform criteria to define remission, response and exacerbation are recommended for clinical trials examining the efficacy and safety of antipsychotic drugs in schizophrenia.
journal_name
Schizophr Resjournal_title
Schizophrenia researchauthors
Aboraya A,Leucht S,Nasrallah HA,Samara M,Haro JM,Elshazly A,Zangeneh Mdoi
10.1016/j.schres.2017.03.020subject
Has Abstractpub_date
2017-12-01 00:00:00pages
123-128eissn
0920-9964issn
1573-2509pii
S0920-9964(17)30139-1journal_volume
190pub_type
杂志文章,评审abstract:BACKGROUND:Self-referential processing (i.e. linking internal and external stimuli to one's own self) has received scant attention thus far in schizophrenia. This type of processing is a key component of social cognition and thought to be important for adaptive social functioning. Memory studies in healthy subjects hav...
journal_title:Schizophrenia research
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更新日期:2011-04-01 00:00:00
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journal_title:Schizophrenia research
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pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Schizophrenia research
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2007.08.010
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2007.08.013
更新日期:2007-12-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2013.04.009
更新日期:2013-07-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
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journal_title:Schizophrenia research
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doi:10.1016/j.schres.2018.12.005
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journal_title:Schizophrenia research
pub_type: 杂志文章,随机对照试验
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更新日期:2014-03-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章,评审
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更新日期:2018-08-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2007.08.027
更新日期:2008-02-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/S0920-9964(96)00095-3
更新日期:1997-02-07 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/0920-9964(95)00087-9
更新日期:1996-05-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章,评审
doi:10.1016/j.schres.2017.05.011
更新日期:2018-02-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2019.07.001
更新日期:2019-09-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2018.10.012
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/s0920-9964(99)00072-9
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pub_type: 杂志文章
doi:10.1016/j.schres.2017.10.035
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journal_title:Schizophrenia research
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doi:10.1016/j.schres.2005.04.005
更新日期:2005-09-15 00:00:00
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pub_type: 杂志文章
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2004.07.004
更新日期:2005-03-01 00:00:00
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pub_type: 杂志文章,评审
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pub_type: 杂志文章
doi:10.1016/j.schres.2014.08.033
更新日期:2015-01-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/j.schres.2015.11.022
更新日期:2016-01-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2005.03.020
更新日期:2005-09-15 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2014.04.003
更新日期:2014-07-01 00:00:00
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journal_title:Schizophrenia research
pub_type: 杂志文章
doi:10.1016/j.schres.2006.07.025
更新日期:2006-12-01 00:00:00