Factors modifying drug and placebo responses in randomized trials for bipolar mania

Factors modifying drug and placebo responses in randomized trials for bipolar mania. Yildiz A, Vieta E, Tohen M, Baldessarini RJ. Source Department of Psychiatry, Dokuz Eylül University, Izmir, Turkey. agul_yildiz@hotmail.com Abstract Randomized placebo-controlled trials (RCTs) are standard for asse...

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Autores: Yildiz, Aysegul, Vieta i Pascual, Eduard, 1963-, Tohen, Mauricio, Baldessarini, Ross J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2011
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/56347
Acceso en línea:https://hdl.handle.net/2445/56347
Access Level:acceso abierto
Palabra clave:Assaigs clínics de medicaments
Placebos
Trastorn bipolar
Drug testing
Placebos (Medicine)
Manic-depressive illness
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spelling Factors modifying drug and placebo responses in randomized trials for bipolar maniaYildiz, AysegulVieta i Pascual, Eduard, 1963-Tohen, MauricioBaldessarini, Ross J.Assaigs clínics de medicamentsPlacebosTrastorn bipolarDrug testingPlacebos (Medicine)Manic-depressive illnessFactors modifying drug and placebo responses in randomized trials for bipolar mania. Yildiz A, Vieta E, Tohen M, Baldessarini RJ. Source Department of Psychiatry, Dokuz Eylül University, Izmir, Turkey. agul_yildiz@hotmail.com Abstract Randomized placebo-controlled trials (RCTs) are standard for assessing efficacy and safety of treatments. We pursued preliminary indications that some factors are associated differentially with responses to placebo or drugs in RCTs for bipolar mania. We meta-analysed data from RCTs to assess influences of study-site count, subjects' age, sex distribution, diagnostic subgroups, clinical features, trial-completion rates, and publication year on mean difference (MD) in mania ratings between intake and final assessments. In 38 RCTs involving 3812 placebo-treated and 6988 drug-treated patients, symptomatic improvement was similar in placebo arms of trials of effective (6.77, 95% CI 5.77-7.76) and ineffective (7.61, 95% CI 5.47-8.75) drugs. Lesser placebo responses (MD) and greater drug-placebo differences (Hedges' g) were associated with fewer study sites, younger patients' age, and male sex. More patients with initial psychotic features and more trial completion in drug arms were associated with greater drug-associated improvement (MD) and drug-placebo contrast (Hedges' g), whereas more mixed-state diagnoses decreased both measures. Identifying modifying factors can support more efficient and cost-effective designs of therapeutic trials. In trials for mania, fewer sites may limit placebo response and enhance drug-placebo contrasts.Cambridge University Press2011info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/56347Articles publicats en revistes (Psicologia Clínica i Psicobiologia)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: http://dx.doi.org/10.1017/S1461145710001641International Journal of Neuropsychopharmacology, 2011, vol. 14, num. 7, p. 863-875http://dx.doi.org/10.1017/S1461145710001641(c) CINP (Collegium Internationale Neuro-Psychopharmacologicum) , 2011info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/563472026-05-27T06:46:51Z
dc.title.none.fl_str_mv Factors modifying drug and placebo responses in randomized trials for bipolar mania
title Factors modifying drug and placebo responses in randomized trials for bipolar mania
spellingShingle Factors modifying drug and placebo responses in randomized trials for bipolar mania
Yildiz, Aysegul
Assaigs clínics de medicaments
Placebos
Trastorn bipolar
Drug testing
Placebos (Medicine)
Manic-depressive illness
title_short Factors modifying drug and placebo responses in randomized trials for bipolar mania
title_full Factors modifying drug and placebo responses in randomized trials for bipolar mania
title_fullStr Factors modifying drug and placebo responses in randomized trials for bipolar mania
title_full_unstemmed Factors modifying drug and placebo responses in randomized trials for bipolar mania
title_sort Factors modifying drug and placebo responses in randomized trials for bipolar mania
dc.creator.none.fl_str_mv Yildiz, Aysegul
Vieta i Pascual, Eduard, 1963-
Tohen, Mauricio
Baldessarini, Ross J.
author Yildiz, Aysegul
author_facet Yildiz, Aysegul
Vieta i Pascual, Eduard, 1963-
Tohen, Mauricio
Baldessarini, Ross J.
author_role author
author2 Vieta i Pascual, Eduard, 1963-
Tohen, Mauricio
Baldessarini, Ross J.
author2_role author
author
author
dc.subject.none.fl_str_mv Assaigs clínics de medicaments
Placebos
Trastorn bipolar
Drug testing
Placebos (Medicine)
Manic-depressive illness
topic Assaigs clínics de medicaments
Placebos
Trastorn bipolar
Drug testing
Placebos (Medicine)
Manic-depressive illness
description Factors modifying drug and placebo responses in randomized trials for bipolar mania. Yildiz A, Vieta E, Tohen M, Baldessarini RJ. Source Department of Psychiatry, Dokuz Eylül University, Izmir, Turkey. agul_yildiz@hotmail.com Abstract Randomized placebo-controlled trials (RCTs) are standard for assessing efficacy and safety of treatments. We pursued preliminary indications that some factors are associated differentially with responses to placebo or drugs in RCTs for bipolar mania. We meta-analysed data from RCTs to assess influences of study-site count, subjects' age, sex distribution, diagnostic subgroups, clinical features, trial-completion rates, and publication year on mean difference (MD) in mania ratings between intake and final assessments. In 38 RCTs involving 3812 placebo-treated and 6988 drug-treated patients, symptomatic improvement was similar in placebo arms of trials of effective (6.77, 95% CI 5.77-7.76) and ineffective (7.61, 95% CI 5.47-8.75) drugs. Lesser placebo responses (MD) and greater drug-placebo differences (Hedges' g) were associated with fewer study sites, younger patients' age, and male sex. More patients with initial psychotic features and more trial completion in drug arms were associated with greater drug-associated improvement (MD) and drug-placebo contrast (Hedges' g), whereas more mixed-state diagnoses decreased both measures. Identifying modifying factors can support more efficient and cost-effective designs of therapeutic trials. In trials for mania, fewer sites may limit placebo response and enhance drug-placebo contrasts.
publishDate 2011
dc.date.none.fl_str_mv 2011
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/56347
url https://hdl.handle.net/2445/56347
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: http://dx.doi.org/10.1017/S1461145710001641
International Journal of Neuropsychopharmacology, 2011, vol. 14, num. 7, p. 863-875
http://dx.doi.org/10.1017/S1461145710001641
dc.rights.none.fl_str_mv (c) CINP (Collegium Internationale Neuro-Psychopharmacologicum) , 2011
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) CINP (Collegium Internationale Neuro-Psychopharmacologicum) , 2011
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Cambridge University Press
publisher.none.fl_str_mv Cambridge University Press
dc.source.none.fl_str_mv Articles publicats en revistes (Psicologia Clínica i Psicobiologia)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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