Literature DB >> 16518380

Clinical trials for antipsychotic drugs: design conventions, dilemmas and innovations.

T Scott Stroup1, Wayne M Alves, Robert M Hamer, Jeffrey A Lieberman.   

Abstract

More than 50 years after the introduction of modern pharmacotherapies for schizophrenia, there remains a tremendous need for therapeutic advances. A second generation of antipsychotic drugs, introduced over the past 15 years, has provided uncertain advantages over the first-generation drugs. This paper reviews the designs of studies that evaluate the effectiveness of putative antipsychotic drugs. Data from the trials needed to achieve regulatory approval do not meet all the needs of clinicians and policy makers. Practical and large, simple trials that evaluate the comparative effectiveness of antipsychotic drugs in real-world settings can help to meet these needs once a drug has reached the market.

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Year:  2006        PMID: 16518380     DOI: 10.1038/nrd1956

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN: 1474-1776            Impact factor:   84.694


  10 in total

1.  Discovery of potential antipsychotic agents possessing pro-cognitive properties.

Authors:  Jelveh Lameh; Krista McFarland; Jorgen Ohlsson; Fredrik Ek; Fabrice Piu; Ethan S Burstein; Ali Tabatabaei; Roger Olsson; Stefania Risso Bradley; Douglas W Bonhaus
Journal:  Naunyn Schmiedebergs Arch Pharmacol       Date:  2011-11-15       Impact factor: 3.000

2.  'Real world' comparison of first- and second-generation antipsychotics in regard to length of inpatient hospitalization and number of re-hospitalizations.

Authors:  Claire Advokat; Benjamin D Hill; Joseph E Comaty
Journal:  Psychiatr Q       Date:  2007-12-01

Review 3.  Methodological issues in current antipsychotic drug trials.

Authors:  Stefan Leucht; Stephan Heres; Johannes Hamann; John M Kane
Journal:  Schizophr Bull       Date:  2008-01-29       Impact factor: 9.306

4.  [Significance of the German Act on the Reform of the Market for Medicinal Products for psychopharmacotherapy].

Authors:  G Gründer
Journal:  Nervenarzt       Date:  2016-04       Impact factor: 1.214

5.  Drug treatment developments in schizophrenia and bipolar mania: latest evidence and clinical usefulness.

Authors:  Erik Johnsen; Rune A Kroken
Journal:  Ther Adv Chronic Dis       Date:  2012-11       Impact factor: 5.091

Review 6.  Conceptual and methodological issues in the design of clinical trials of antipsychotics for the treatment of schizophrenia.

Authors:  William G Honer; Allen E Thornton; Megan Sherwood; G William MacEwan; Tom S Ehmann; Richard Williams; Lili C Kopala; Ric Procyshyn; Alasdair M Barr
Journal:  CNS Drugs       Date:  2007       Impact factor: 5.749

Review 7.  Randomized controlled trials for schizophrenia: study designs targeted to distinct goals.

Authors:  T Scott Stroup; John R Geddes
Journal:  Schizophr Bull       Date:  2008-01-31       Impact factor: 9.306

8.  Psychiatric disorder criteria and their application to research in different racial groups.

Authors:  Nancy C P Low; John Hardy
Journal:  BMC Psychiatry       Date:  2007-01-10       Impact factor: 3.630

9.  The "RCT augmentation": a novel simulation method to add patient heterogeneity into phase III trials.

Authors:  Helene Karcher; Shuai Fu; Jie Meng; Mikkel Zöllner Ankarfeldt; Orestis Efthimiou; Mark Belger; Josep Maria Haro; Lucien Abenhaim; Clementine Nordon
Journal:  BMC Med Res Methodol       Date:  2018-07-06       Impact factor: 4.615

10.  Innovations in clinical research design and conduct in psychiatry: shifting to pragmatic approaches.

Authors:  David M Marks; Thanaseelan J; Chi-Un Pae
Journal:  Psychiatry Investig       Date:  2009-03-31       Impact factor: 2.505

  10 in total

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