Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force

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Arquivos
art_MISKOWIAK_Methodological_recommendations_for_cognition_trials_in_bipolar_disorder_2017.PDF (473.13 KB)
Citações na Scopus
140
Tipo de produção
article
Data de publicação
2017
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
WILEY
Autores
MISKOWIAK, K. W.
BURDICK, K. E.
MARTINEZ-ARAN, A.
BONNIN, C. M.
BOWIE, C. R.
CARVALHO, A. F.
GALLAGHER, P.
LOPEZ-JARAMILLO, C.
SUMIYOSHI, T.
Citação
BIPOLAR DISORDERS, v.19, n.8, p.614-626, 2017
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
ObjectivesTo aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. MethodsThe task force was launched in September 2016, consisting of 18 international experts from nine countries. A series of methodological issues were identified based on literature review and expert opinion. The issues were discussed and expanded upon in an initial face-to-face meeting, telephone conference call and email exchanges. Based upon these exchanges, recommendations were achieved. ResultsKey methodological challenges are: lack of consensus on how to screen for entry into cognitive treatment trials, define cognitive impairment, track efficacy, assess functional implications, and manage mood symptoms and concomitant medication. Task force recommendations are to: (i) enrich trials with objectively measured cognitively impaired patients; (ii) generally select a broad cognitive composite score as the primary outcome and a functional measure as a key secondary outcome; and (iii) include remitted or partly remitted patients. It is strongly encouraged that trials exclude patients with current substance or alcohol use disorders, neurological disease or unstable medical illness, and keep non-study medications stable. Additional methodological considerations include neuroimaging assessments, targeting of treatments to illness stage and using a multimodal approach. ConclusionsThis ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy in future trials and increase comparability between studies.
Palavras-chave
bipolar disorder, cognitive impairment, methodology, recommendations, treatment
URI
https://observatorio.fm.usp.br/handle/OPI/25668
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MPS
Artigos e Materiais de Revistas Científicas - LIM/21
Artigos e Materiais de Revistas Científicas - ODS/03